This Study is Done in Patients With Plaque Psoriasis and... | NCT03635099 | Trialant
NCT03635099
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Aug 3, 2022Actual
Enrollment
274Actual
Phase
Phase 2
Conditions
Psoriasis
Interventions
Placebo (fasted)
BI 25 mg (fasted)
BI 50 mg (fasted)
BI 100 mg (fasted)
BI 200 mg (fasted)
Placebo (fed)
BI 400 mg once daily (fed)
BI 200 mg twice daily, 400 mg total (fed)
Countries
United States
Canada
Germany
Protocol Section
Identification Module
NCT ID
NCT03635099
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1407-0030
Secondary IDs
ID
Type
Description
Link
2017-004659-21
EudraCT Number
Brief Title
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Official Title
Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Jul 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 17, 2018Actual
Primary Completion Date
May 6, 2021Actual
Completion Date
May 26, 2021Actual
First Submitted Date
Aug 15, 2018
First Submission Date that Met QC Criteria
Aug 15, 2018
First Posted Date
Aug 17, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 5, 2022
Results First Submitted that Met QC Criteria
May 5, 2022
Results First Posted Date
Jun 2, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 8, 2022
Last Update Posted Date
Aug 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
274Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part I - Placebo (fasted)
Placebo Comparator
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Drug: Placebo (fasted)
Part I - BI 25 mg (fasted)
Experimental
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Drug: BI 25 mg (fasted)
Part I - BI 50 mg (fasted)
Experimental
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Drug: BI 50 mg (fasted)
Part I - BI 100 mg (fasted)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo (fasted)
Drug
Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Assesment at week 12 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Assesment at week 12 of treatment
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 50 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction.
No hypothesis testing was planned or carried out for Part II.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female patients. Woman Of Childbearing Potential (WoCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
Age 18 to 75 years (both inclusive) at screening
BMI < 35 kg/m2 at screening
Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient
Patients must be candidates for systemic PsO therapy.Moderate-to-severe plaque psoriasis:
BSA ≥10% and
PASI ≥12 and
sPGA moderate or severe
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion Criteria:
Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to Inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations
Previous enrolment in this trial or previous exposure to BI 730357.
Current enrollment in another investigational device or drug trial, or is less than 30 days (from randomisation) since ending another investigational device or drug trial(s), or receipt of other investigational treatment(s).
Use of
any biologic agent within 12 weeks, or
any anti IL-23 biologic agent within 24 weeks prior to randomisation, or
systemic anti-psoriatic medications or phototherapy within 4 weeks prior to randomisation, or
topical anti-psoriasis medications within 2 weeks prior to randomisation
Receipt of a live vaccination within 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this trial
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g., hip replacement
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix
Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis, candidiasis and tuberculosis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
Evidence of a current or previous disease (including known or suspected IBD, and cardiovascular disease), or medical finding that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e., active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
Unwillingness to adhere to the rules of UV-light protection
Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details
This trial was a 2-part, randomised, placebo-controlled, double-blind, parallel-group, dose-ranging trial to investigate the efficacy, safety, and tolerability of different dose regimens of BI 730357 in patients with moderate-to-severe plaque psoriasis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 24, 2020
May 5, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Drug: BI 100 mg (fasted)
Part I - BI 200 mg (fasted)
Experimental
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Drug: BI 200 mg (fasted)
Part II - Placebo (fed)
Placebo Comparator
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Drug: Placebo (fed)
Part II - BI 400 mg once daily (fed)
Experimental
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Drug: BI 400 mg once daily (fed)
Part II - BI 200 mg twice daily, 400 mg total (fed)
Experimental
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Drug: BI 200 mg twice daily, 400 mg total (fed)
Part I - Placebo (fasted)
BI 25 mg (fasted)
Drug
25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Part I - BI 25 mg (fasted)
BI 50 mg (fasted)
Drug
50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Part I - BI 50 mg (fasted)
BI 100 mg (fasted)
Drug
100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Part I - BI 100 mg (fasted)
BI 200 mg (fasted)
Drug
200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Part I - BI 200 mg (fasted)
Placebo (fed)
Drug
4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Part II - Placebo (fed)
BI 400 mg once daily (fed)
Drug
4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
Part II - BI 400 mg once daily (fed)
BI 200 mg twice daily, 400 mg total (fed)
Drug
2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Part II - BI 200 mg twice daily, 400 mg total (fed)
Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 90 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 90 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 90.
Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 100 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 100 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 100.
Assesment at week 12 of treatment
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at weeks 16, 20 and 24. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
Assesment at week 16, 20 and 24 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
Number of patients who achieved a static Physician's Global Assessment score of 'clear' (sPGA 0) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Assesment at week 12 of treatment
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 16, 20 and 24. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Assesment at week 16, 20 and 24 of treatment
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
Overall change from baseline in psoriasis symptoms evaluated using the total score of the Psoriasis Symptoms Scale (PSS) at Week 12. The PSS is a four-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis.
Current symptom severity is assessed for a 24 hour recall period using a 5-point verbal rating scale, the PSS score ranges from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 to 16).
Presented 'Mean' values are actually 'Adjusted Mean'. No hypothesis testing was planned or carried out for Part II.
Assesment at week 12 of treatment
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
Number of patients who achieved a Dermatology Life Quality Index score of 'no effect on patient's life' (DLQI 0/1) at Week 12. The DLQI is a subject-administered, ten-question, quality of life questionnaire covering 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Item scores range from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on subject's life. The higher the score, the more the quality of life is impaired. A 4-point change from baseline is considered a clinically important difference. No hypothesis testing was planned or carried out for Part II.
Assesment at week 12 of treatment
Los Angeles
California
90045
United States
Southern California Dermatology Inc.
Santa Ana
California
92701
United States
Hamilton Research
Alpharetta
Georgia
30022
United States
Advanced Medical Research PC
Sandy Springs
Georgia
30328
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46250
United States
The Psoriasis Treatment Center of Central New Jersey
Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
FG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
FG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
FG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
FG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
FG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
FG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
FG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
FG00020 subjects
FG00140 subjects
FG00239 subjects
FG00339 subjects
FG00440 subjects
FG00510 subjects
FG00644 subjects
FG00742 subjects
Full Analysis Set (FAS)
FG00020 subjects
FG00140 subjects
FG00239 subjects
FG00339 subjects
FG00440 subjects
FG00510 subjects
FG00643 subjects
FG00742 subjects
COMPLETED
Completed period 1: completed 12 weeks of treatment.
FG00016 subjects
FG00137 subjects
FG00231 subjects
FG00334 subjects
FG00437 subjects
FG0059 subjects
FG00640 subjects
FG00740 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0028 subjects
FG0035 subjects
FG0043 subjects
FG0051 subjects
FG0064 subjects
FG0072 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
FG0025 subjects
FG0032 subjects
FG004
History of suicidal ideation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
pursue other treatment options
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not Eligible for Period 2
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00137 subjects
FG00231 subjects
FG00334 subjects
FG00437 subjects
FG0059 subjects
FG00640 subjects
FG00740 subjects
COMPLETED
Completed subjects moved to period 2. Not completed did not move to period 2.
FG00015 subjects
FG00137 subjects
FG00231 subjects
FG003
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Eligible for Period 2
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00137 subjects
FG00231 subjects
FG00333 subjects
FG00437 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Switching Patients
Non-responding patients in dose groups were switched at the end of period 1 to a higher dose group.
FG00015 subjectsSwitched to the 'BI 200 mg' dose group.
FG00135 subjectsSwitched to the 'BI 50 mg' dose group.
FG00221 subjectsSwitched to the 'BI 100 mg' dose group.
FG003
Non Switching Patients
Patients stayed in initially randomized treatment group.
FG0000 subjects
FG0012 subjects
FG00210 subjects
FG003
COMPLETED
FG0000 subjects
FG0012 subjects
FG00210 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG00015 subjects
FG00135 subjects
FG00221 subjects
FG00325 subjects
FG004
Type
Comment
Reasons
Switch to higher dose at end of period 1
FG00015 subjects
FG00135 subjects
FG00221 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0012 subjects
FG00245 subjectsCombination of period 1 dose groups: "BI 50 mg" and switched patients from dose Group "BI 25 mg"
FG00329 subjectsCombination of period 1 dose groups: "BI 100 mg" and switched patients from dose Group "BI 50 mg"
FG00477 subjectsCombination of period 1: "BI 200mg", switched patients from dose Group "BI 100 mg" and "Placebo".
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG00236 subjects
FG00325 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0029 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
BG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
BG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
BG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
BG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
BG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
BG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
BG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00140
BG00239
BG00339
BG00440
BG00510
BG00643
BG00742
BG008273
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.1± 14.7
BG00147.2± 13.7
BG00246.3± 15.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0019
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Psoriasis Area Severity Index score (PASI)
The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
Mean
Standard Deviation
Score on scale
Title
Denominators
Categories
Title
Measurements
BG00017.1± 5.2
BG001
Static Physician's Global Assessment score (sPGA)
The sPGA is a 5 point score (0 to 4) based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear , 1 almost clear, 2 mild, 3 moderate and 5 severe. Reported are the number of subjects with a moderate (dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling) and severe (bright to deep dark red coloration, severe thickening with hard edges, severe coarse scaling covering almost all or all lesions) score.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Moderate
BG00016
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Units
Counts
Participants
OG00020
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0023
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
0.3091
Risk Difference (RD)
5.0
2-Sided
95
-1.8
11.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
Primary
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 50 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reduction.
No hypothesis testing was planned or carried out for Part II.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 90 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 90 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 90.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 100 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 100 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduction.
No statistical comparisons were planned or carried out for Part 2 of the trial. Statistical analysis could not be performed for arms with 0 participants reaching PASI 100.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at weeks 16, 20 and 24. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. Higher scores indicating higher severity, while a score of 0 indicates no disease.
PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures. Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 16, 20 and 24 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
Number of patients who achieved a static Physician's Global Assessment score of 'clear' (sPGA 0) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
No statistical comparisons were planned or carried out for Part 2 of the trial.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24
Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 16, 20 and 24. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Full Analysis Set (FAS): The FAS includes all patients who received at least 1 dose of trial medication and provided baseline and at least 1 post-randomisation measurement of Psoriasis Area Severity Index (PASI). Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 16, 20 and 24 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
Overall change from baseline in psoriasis symptoms evaluated using the total score of the Psoriasis Symptoms Scale (PSS) at Week 12. The PSS is a four-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis.
Current symptom severity is assessed for a 24 hour recall period using a 5-point verbal rating scale, the PSS score ranges from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 to 16).
Presented 'Mean' values are actually 'Adjusted Mean'. No hypothesis testing was planned or carried out for Part II.
Full Analysis Set (FAS): All patients who received at least 1 dose of trial medication and provided a baseline and at least 1 postrandomisation measurement of PASI. Only participants with non-missing values are reported.
Posted
Mean
Standard Error
Total score
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Secondary
Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
Number of patients who achieved a Dermatology Life Quality Index score of 'no effect on patient's life' (DLQI 0/1) at Week 12. The DLQI is a subject-administered, ten-question, quality of life questionnaire covering 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Item scores range from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on subject's life. The higher the score, the more the quality of life is impaired. A 4-point change from baseline is considered a clinically important difference. No hypothesis testing was planned or carried out for Part II.
Full Analysis Set (FAS): All patients who received at least 1 dose of trial medication and provided a baseline and at least 1 postrandomisation measurement of PASI. Subjects with missing data for subsequent visits were included but those entries were imputed as failures.
Posted
Count of Participants
Participants
Assesment at week 12 of treatment
ID
Title
Description
OG000
Part I - Placebo (Fasted)
Part I - Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 75 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
Time Frame
Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II.
Description
Treated Set (TS): The TS includes all randomized patients who received at least 1 dose of trial medication and is based on the actual treatment received at randomization visit and week 12 visit, if applicable.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part I - Period 1 - Fasted: Placebo
Part I - Period 1 - fasted: Placebo matching BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
0
5
0
5
4
5
EG001
Part I - Period 1 - Fasted: BI 25 mg
Part I - Period 1 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
0
3
0
3
2
3
EG002
Part I - Period 1 - Fasted: BI 50 mg
Part I - Period 1 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
0
8
0
8
2
8
EG003
Part I - Period 1 - Fasted: BI 100 mg
Part I - Period 1 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
0
6
0
6
2
6
EG004
Part I - Period 1 - Fasted: BI 200 mg
Part I - Period 1 - fasted: 200 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted. Participants in this arm only participated in period 1 and did not enter period 2.
0
3
0
3
3
3
EG005
Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg
Part I - Period 1 and 2 - fasted: Placebo participants in period who failed to achieve a PASI 75 response at Week 12 and were switched to a 200 mg dose in period 2.
0
15
0
15
9
15
EG006
Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg
Part I - Period 1 and 2 - fasted: 25 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 25 mg dose in period 2.
0
2
0
2
1
2
EG007
Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg
Part I - Period 1 and 2 - fasted: Participants assigned 25 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 50 mg dose in period 2.
0
35
2
35
15
35
EG008
Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg
Part I - Period 1 and 2 - fasted: 50 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 50 mg dose in period 2.
0
10
0
10
7
10
EG009
Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg
Part I - Period 1 and 2 - fasted: Participants assigned 50 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 100 mg dose in period 2.
0
21
1
21
13
21
EG010
Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg
Part I - Period 1 and 2 - fasted: 100 milligram (mg) BI 730357 taken orally daily as a film-coated tablet in the morning while fasted in period 1. Participants who achieved a PASI 50 response at Week 12 and stayed on a 100 mg dose in period 2.
0
8
0
8
7
8
EG011
Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg
Part I - Period 1 and 2 - fasted: Participants assigned 100 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who failed to achieve a PASI 50 response at Week 12 and were switched to a 200 mg dose in period 2.
0
25
0
25
12
25
EG012
Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg
Part I - Period 1 and 2 - fasted: Participants assigned 200 milligram (mg) BI 730357 in period 1 (taken orally daily as a film-coated tablet in the morning while fasted) who remained on the 200 mg throughout period 1 and 2.
0
37
0
37
18
37
EG013
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
0
10
0
10
5
10
EG014
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
0
44
0
44
9
44
EG015
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
0
42
0
42
8
42
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG0030 affected6 at risk
EG004
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG0030 affected6 at risk
EG0041 affected3 at risk
EG0050 affected15 at risk
EG0060 affected2 at risk
EG0070 affected35 at risk
EG0080 affected10 at risk
EG0090 affected21 at risk
EG0100 affected8 at risk
EG0110 affected25 at risk
EG0120 affected37 at risk
EG0130 affected10 at risk
EG0140 affected44 at risk
EG0150 affected42 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Photophobia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Localised infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Otitis media
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Nail avulsion
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Electrocardiogram ST segment depression
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Liver function test increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Occult blood positive
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected8 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Uterine spasm
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0021 affected8 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Defect conduction intraventricular
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Cataract
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
39
OG00440
OG00510
OG00643
OG00742
4
OG00412
OG0050
OG00611
OG00710
0.2030
Risk Difference (RD)
7.7
2-Sided
95
-0.7
16.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.1380
Risk Difference (RD)
10.3
2-Sided
95
0.7
19.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0062
Risk Difference (RD)
30.0
2-Sided
95
15.8
44.2
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG006
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
25.6
2-Sided
95
12.5
38.6
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG007
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
23.8
2-Sided
95
10.9
36.7
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG001
OG002
OG003
OG004
MCPMod Linear model fit.
0.0004
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Logistic model fit.
Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.
0.0012
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Emax1 model fit.
Model assumption: 30% of the maximum effect is achieved at 50 mg.
0.0008
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Emax2 model fit.
Model assumption: 80% of the maximum effect is achieved at 50 mg.
0.0217
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Exponential model fit.
Model assumption: 5% of the maximum effect is achieved at 25 mg.
0.0004
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0023
OG0032
OG00411
OG0050
OG00611
OG00710
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
0.4758
Risk Difference (RD)
2.5
2-Sided
95
-2.3
7.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.2030
Risk Difference (RD)
7.7
2-Sided
95
-0.7
16.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.3028
Risk Difference (RD)
5.1
2-Sided
95
-1.8
12.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0095
Risk Difference (RD)
27.5
2-Sided
95
13.7
41.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG001
OG002
OG003
OG004
MCPMod Linear model fit.
0.0007
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Logistic model fit.
Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.
0.0023
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Emax1 model fit.
Model assumption: 30% of the maximum effect is achieved at 50 mg.
0.0018
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Emax2 model fit.
Model assumption: 80% of the maximum effect is achieved at 50 mg.
0.0386
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG000
OG001
OG002
OG003
OG004
MCPMod Exponential model fit.
Model assumption: 5% of the maximum effect is achieved at 25 mg.
0.0004
The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.
Other
First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG00210
OG0038
OG00420
OG0051
OG00624
OG00719
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
1.0000
Risk Difference (RD)
0.0
2-Sided
95
-11.7
11.7
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.0540
Risk Difference (RD)
20.6
2-Sided
95
3.9
37.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.1167
Risk Difference (RD)
15.5
2-Sided
95
-0.4
31.4
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0006
Risk Difference (RD)
45.0
2-Sided
95
26.8
63.2
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG006
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
45.8
2-Sided
95
22.0
69.6
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG007
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
35.2
2-Sided
95
11.3
59.2
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0047
OG0050
OG0064
OG0072
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Chi-squared
0.3028
Risk Difference (RD)
5.1
2-Sided
95
-1.8
12.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.4701
Risk Difference (RD)
2.6
2-Sided
95
-2.4
7.5
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0465
Risk Difference (RD)
17.5
2-Sided
95
5.7
29.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG006
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
9.3
2-Sided
95
0.6
18.0
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG007
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
4.8
2-Sided
95
-1.7
11.2
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0042
OG0050
OG0061
OG0072
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Chi-squared
0.4701
Risk Difference (RD)
2.6
2-Sided
95
-2.4
7.5
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.3091
Risk Difference (RD)
5.0
2-Sided
95
-1.8
11.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG006
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
2.3
2-Sided
95
-2.2
6.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG007
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
2.4
2-Sided
95
-2.2
7.0
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
Title
Denominators
Categories
Week 16
Title
Measurements
OG0000
OG0011
OG0021
OG0035
OG00411
Week 20
Title
Measurements
OG0000
OG0012
OG0023
OG003
Week 24
Title
Measurements
OG0000
OG0012
OG0024
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
0.4758
Risk Difference (RD)
2.5
2-Sided
95
-2.3
7.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.4701
Risk Difference (RD)
2.6
2-Sided
95
-2.4
7.5
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.0942
Risk Difference (RD)
12.8
2-Sided
95
2.3
23.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0095
Risk Difference (RD)
27.5
2-Sided
95
13.7
41.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG001
Chi-squared
0.3091
Risk Difference (RD)
5.0
2-Sided
95
-1.8
11.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.2030
Risk Difference (RD)
7.7
2-Sided
95
-0.7
16.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.1380
Risk Difference (RD)
10.3
2-Sided
95
0.7
19.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0040
Risk Difference (RD)
32.5
2-Sided
95
18.0
47.0
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.1380
Risk Difference (RD)
10.3
2-Sided
95
0.7
19.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0025
Risk Difference (RD)
35.0
2-Sided
95
20.2
49.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0042
OG0050
OG0061
OG0071
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Chi-squared
0.4701
Risk Difference (RD)
2.6
2-Sided
95
-2.4
7.5
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.3091
Risk Difference (RD)
5.0
2-Sided
95
-1.8
11.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
Title
Denominators
Categories
Week 16
Title
Measurements
OG0000
OG0011
OG0022
OG0033
OG00412
Week 20
Title
Measurements
OG0000
OG0011
OG0024
OG003
Week 24
Title
Measurements
OG0000
OG0011
OG0023
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
0.4758
Risk Difference (RD)
2.5
2-Sided
95
-2.3
7.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.3028
Risk Difference (RD)
5.1
2-Sided
95
-1.8
12.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.2030
Risk Difference (RD)
7.7
2-Sided
95
-0.7
16.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0062
Risk Difference (RD)
30.0
2-Sided
95
15.8
44.2
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.1380
Risk Difference (RD)
10.3
2-Sided
95
0.7
19.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.3028
Risk Difference (RD)
5.1
2-Sided
95
-1.8
12.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0143
Risk Difference (RD)
25.0
2-Sided
95
11.6
38.4
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.2030
Risk Difference (RD)
7.7
2-Sided
95
-0.7
16.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.1380
Risk Difference (RD)
10.3
2-Sided
95
0.7
19.8
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.0040
Risk Difference (RD)
32.5
2-Sided
95
18.0
47.0
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00238
OG00338
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG000-0.4± 1.0
OG0010.1± 0.7
OG0020.2± 0.7
OG0032.3± 0.7
OG0043.6± 0.7
OG0050.3± 1.2
OG0063.4± 0.6
OG0073.3± 0.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Mixed Model Repeated Measures (MMRM)
0.7008
Adjusted mean
0.5
Standard Error of the Mean
1.2
2-Sided
95
-1.9
2.8
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG000
OG002
Mixed Models Analysis
Mixed Model Repeated Measures (MMRM)
0.6268
Adjusted mean
0.6
Standard Error of the Mean
1.2
2-Sided
95
-1.8
3.0
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG000
OG003
Mixed Models Analysis
Mixed Model Repeated Measures (MMRM)
0.0266
Adjusted mean
2.7
Standard Error of the Mean
1.2
2-Sided
95
0.3
5.1
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG000
OG004
Mixed Models Analysis
Mixed Model Repeated Measures (MMRM)
0.0009
Adjusted mean
4.0
Standard Error of the Mean
1.2
2-Sided
95
1.7
6.3
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG005
OG006
Adjusted mean
3.1
Standard Error of the Mean
1.4
2-Sided
95
0.4
5.8
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG005
OG007
Adjusted mean
3.1
Standard Error of the Mean
1.4
2-Sided
95
0.4
5.8
MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.
Other
OG001
Part I - BI 25 mg (Fasted)
Part I - 25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 50 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG002
Part I - BI 50 mg (Fasted)
Part I - 50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 100 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG003
Part I - BI 100 mg (Fasted)
Part I - 100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks). Participants who failed to achieve a Psoriasis Area Severity Index score (PASI) 50 response at Week 12 were switched to a 200 mg dose, participants switching dose were imputed as failure for records after week 12, under original randomized treatment arm.
OG004
Part I - BI 200 mg (Fasted)
Part I - 200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).
OG005
Part II - Placebo (Fed)
Part II - 4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG006
Part II - BI 400 mg Once Daily (Fed)
Part II - 4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.
OG007
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)
Part II - 2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.
Units
Counts
Participants
OG00020
OG00140
OG00239
OG00339
OG00440
OG00510
OG00643
OG00742
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0048
OG0052
OG00612
OG00711
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
0.7144
Risk Difference (RD)
2.5
2-Sided
95
-10.1
15.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG002
Chi-squared
0.6970
Risk Difference (RD)
2.7
2-Sided
95
-10.0
15.4
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG003
Chi-squared
0.6970
Risk Difference (RD)
2.7
2-Sided
95
-10.0
15.4
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG000
OG004
Chi-squared
0.1250
Risk Difference (RD)
15.0
2-Sided
95
-0.6
30.6
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG006
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
7.9
2-Sided
95
-20.3
36.1
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).
Other
OG005
OG007
The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.
Risk Difference (RD)
6.2
2-Sided
95
-21.9
34.3
Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).