BI 655066 (Risankizumab) Proof of Concept Dose Finding St... | NCT02047110 | Trialant
NCT02047110
Sponsor
AbbVie
Status
Completed
Last Update Posted
May 31, 2019Actual
Enrollment
159Actual
Phase
Phase 2
Conditions
Ankylosing Spondylitis (AS)
Interventions
placebo for risankizumab
risankizumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02047110
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1311.8
Secondary IDs
ID
Type
Description
Link
2013-003666-13
EudraCT Number
Brief Title
BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
Official Title
A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2019
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
Jan 28, 2014Actual
Primary Completion Date
Mar 5, 2015Actual
Completion Date
Jul 25, 2016Actual
First Submitted Date
Jan 24, 2014
First Submission Date that Met QC Criteria
Jan 24, 2014
First Posted Date
Jan 28, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 3, 2019
Results First Submitted that Met QC Criteria
May 30, 2019
Results First Posted Date
May 31, 2019Actual
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
May 30, 2019
Last Update Posted Date
May 31, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Boehringer Ingelheim
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.
Detailed Description
Not provided
Conditions Module
Conditions
Ankylosing Spondylitis (AS)
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
159Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Drug: placebo for risankizumab
Risankizumab 18 mg
Experimental
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Drug: risankizumab
Risankizumab 90 mg
Experimental
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Drug: risankizumab
Risankizumab 180 mg
Experimental
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Drug: risankizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
placebo for risankizumab
Drug
Placebo for risankizumab administered by subcutaneous (SC) injection
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
Global AS disease activity
Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
Spinal pain based on the mean of 2 questions
Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
This is the key secondary endpoint. ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient's global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit. ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1). For all of the scales that make up the ASDAS, higher indicates worse disease.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Male and female patients
Age = 18 years and = 70 years
Definite AS based on the modified New York criteria (1984)
Documented disease duration = 3 months at screening
Active disease at screening, defined as:
BASDAI score (0-10) = 4, AND
Spinal pain level assessed by the 2nd BASDAI question (0-10) = 4
Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
Female patients who meet any of the following criteria from screening visit up to the End of Observation visit (EOO):
using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
sexually abstinent
have a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
surgically sterilised (including hysterectomy)
postmenopausal defined as at least 1 year of spontaneous Amenorrhea
Patients (males or females) receiving background MTX or Leflunomide therapy who are following the national regulatory guidelines regarding contraception
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
Radiographic evidence of total ankylosis of the spine at screening or before (spinal XRay examinations at screening visit/ during screening period are not mandatory ¿ see footnote 12 from Flow-Chart 1)
Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
Previous or current participation in a clinical trial testing an investigational drug for AS within 12 weeks prior to randomization (any biological immunomodulating agents are excluded)
Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
Active uveitis or inflammatory bowel disease at screening
Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
Patients who must or wish to continue the intake of restricted medications (cf. Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the study
Major surgery performed within 8 weeks prior to screening or planned within 12 months after screening (e.g. hip replacement)
Chronic or relevant acute infections including HIV, viral hepatitis and tuberculosis (positive tests for HIV, HBV/HCV at screening will be exclusionary)
For tuberculosis patients, they are not eligible according to the following screening criteria:
Have signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist)
Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or during screening, in which active TB has not been ruled out, except for patients with history of latent TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
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 or in situ carcinoma of uterine cervix
Evidence of current or previous clinically significant disease, medical condition other than AS, finding of the medical examination (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that is of clinical relevance, that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
History of alcohol abuse within last 12 months (intake of more than 30 g/day)
The trial had a double blind (DB) treatment period up to Week 24, an Escape treatment period up to Week 40, and an open-label-extension (OLE) treatment period that lasted 26 weeks after OLE entry. Each of the treatment periods was followed by a 24- week post-treatment follow-up period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
FG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
FG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
FG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Periods
Title
Milestones
Reasons Not Completed
DB Treatment Period up to Week 24
Type
Comment
Milestone Data
STARTED
FG00040 subjectsStarted are the treated patients
FG00140 subjectsStarted are the treated patients
FG00239 subjectsStarted are the treated patients
FG00340 subjectsStarted are the treated patients
COMPLETED
FG00035 subjects
FG00138 subjects
FG00236 subjects
FG00338 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
DB (Week 12 up to Week 24)
Type
Comment
Milestone Data
STARTED
FG0009 subjectsPatients who continued treatment in the DB treatment period up to Week 24
FG00117 subjectsPatients who continued treatment in the DB treatment period up to Week 24
FG00213 subjectsPatients who continued treatment in the DB treatment period up to Week 24
FG003
Escape Treatment Period
Type
Comment
Milestone Data
STARTED
FG00026 subjectsAssessment in SpondyloArthritis international Society (ASAS) 20 nonresponders
FG00121 subjectsASAS 20 nonresponders
FG00223 subjectsASAS 20 nonresponders
FG003
OLE Treatment Period
Type
Comment
Milestone Data
STARTED
FG0004 subjectsPatients with loss of ASAS 20 response compared with baseline
FG0018 subjectsPatients with loss of ASAS 20 response compared with baseline
FG0025 subjectsPatients with loss of ASAS 20 response compared with baseline
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Treated set (TS): All patients who received at least 1 dose of trial medication
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
BG001
Risankizumab 18 mg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
Global AS disease activity
Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
Spinal pain based on the mean of 2 questions
Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
Adverse Events Module
Frequency Threshold
5
Time Frame
All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
Description
Not provided
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
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Inguinal hernia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
More Info Module
Limitations and Caveats
The hierarchical testing p-values are exploratory in nature, due to the study design, as the primary endpoint of study failed to meet the desired objective.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
AbbVie
800-633-9110
abbvieclinicaltrials@abbvie.com
Jul 10, 2026
Removed Countries
Belgium
Finland
France
Germany
Hong Kong
Italy
Netherlands
South Korea
Spain
Taiwan
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D013167
Spondylitis, Ankylosing
Ancestor Terms
ID
Term
D000089183
Axial Spondyloarthritis
D025242
Spondylarthropathies
D025241
Spondylarthritis
D013166
Spondylitis
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000601773
risankizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
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
Not provided
risankizumab
Drug
Risankizumab administered by subcutaneous (SC) injection
Risankizumab 18 mg
Risankizumab 180 mg
Risankizumab 90 mg
ABBV-066
BI 655066
SKYRIZI
Baseline and Week 12
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
The ASAS 5/6 evaluation is based on 6 components:
Global AS disease activity
Inflammation based on the mean of BASDAI questions addressing the level-of morning stiffness and duration
Spinal pain
Physical function based on the Bath AS Functional Index (BASFI)
Spinal mobility assessment (lateral lumbar flexion), corresponding to one out of 5 measurements of Bath Ankylosing Spondylitis Metrology Index (BASMI)
Serum CRP levels The ASAS 5/6 response is defined as an improvement in any 5 of the 6 components and no worsening in the remaining component. A reduction from baseline of ≥20% is defined as an improvement according to the ASAS criteria.
Week 12
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Week 12
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
Global AS disease activity
Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
Spinal pain based on the mean of 2 questions
Physical function based on the Bath AS Functional Index (BASFI) The ASAS 20 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥20% and an absolute reduction of ≥1 units in each of the 3 components.
Week 12
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of
fatigue/tiredness you have experienced?
AS neck, back or hip pain you have had?
pain/swelling in joints other than neck, back or hips you have had?
discomfort you have had from any areas tender to touch or pressure?
morning stiffness you have had from the time you wake up? How long does your
morning stiffness last from the time you wake up?
A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h.
The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5.
Baseline and Week 12
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
Week 24
0 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Other than specified
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
12 subjects
Patients who continued treatment in the DB treatment period up to Week 24
COMPLETED
FG0009 subjects
FG00115 subjects
FG00212 subjects
FG00312 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Other than specified
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
26 subjects
ASAS 20 nonresponders
COMPLETED
FG00023 subjects
FG00115 subjects
FG00220 subjects
FG00324 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0032 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
Other than specified
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
9 subjects
Patients with loss of ASAS 20 response compared with baseline
COMPLETED
FG0004 subjects
FG0018 subjects
FG0024 subjects
FG0039 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Type
Comment
Reasons
Other than specified
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
BG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
BG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
BG004
Total
Total of all reporting groups
40
BG00140
BG00239
BG00340
BG004159
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00037.6± 11.0
BG00138.0± 11.1
BG00239.5± 10.8
BG00340.6± 11.9
BG00438.9± 11.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00112
BG0029
BG00310
BG00446
Male
BG00025
BG00128
BG00230
BG00330
BG004
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG00340
Title
Denominators
Categories
Title
Measurements
OG00017.5
OG00125.0
OG00220.5
OG00315.0
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
To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Suissa-Shuster unconditional exact test
0.2652
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.
Risk Difference (RD)
7.5
2-Sided
90
-12.1
26.6
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
OG000
OG002
To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Suissa-Shuster unconditional exact test
0.4129
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.
Risk Difference (RD)
3.0
2-Sided
90
-15.9
20.8
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Suissa-Shuster unconditional exact test
0.4243
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups
Risk Difference (RD)
-2.5
2-Sided
90
-21.8
17.0
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
Secondary
Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
This is the key secondary endpoint. ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient's global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit. ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1). For all of the scales that make up the ASDAS, higher indicates worse disease.
FAS
Posted
Median
Inter-Quartile Range
Unit on scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.2(-0.9 to 0.2)
OG001-0.7(-1.3 to -0.2)
OG002-0.6(-1.0 to 0.1)
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
Wilcoxon rank-sum test
0.0229
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
-0.4
2-Sided
90
-0.7
-0.1
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
Secondary
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
The ASAS 5/6 evaluation is based on 6 components:
Global AS disease activity
Inflammation based on the mean of BASDAI questions addressing the level-of morning stiffness and duration
Spinal pain
Physical function based on the Bath AS Functional Index (BASFI)
Spinal mobility assessment (lateral lumbar flexion), corresponding to one out of 5 measurements of Bath Ankylosing Spondylitis Metrology Index (BASMI)
Serum CRP levels The ASAS 5/6 response is defined as an improvement in any 5 of the 6 components and no worsening in the remaining component. A reduction from baseline of ≥20% is defined as an improvement according to the ASAS criteria.
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG00120.0
OG00223.1
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
Suissa-Shuster unconditional exact test
0.0238
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Risk Difference (RD)
15.0
2-Sided
90
-4.6
33.8
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
Secondary
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.5
OG0012.5
OG0022.6
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
p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Risk Difference (RD)
0
2-Sided
90
-19.4
19.4
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
Secondary
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
Global AS disease activity
Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
Spinal pain based on the mean of 2 questions
Physical function based on the Bath AS Functional Index (BASFI) The ASAS 20 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥20% and an absolute reduction of ≥1 units in each of the 3 components.
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00145.0
OG00233.3
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
Suissa-Shuster unconditional exact test
0.0092
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Risk Difference (RD)
25.0
2-Sided
90
5.5
43.1
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
Secondary
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of
fatigue/tiredness you have experienced?
AS neck, back or hip pain you have had?
pain/swelling in joints other than neck, back or hips you have had?
discomfort you have had from any areas tender to touch or pressure?
morning stiffness you have had from the time you wake up? How long does your
morning stiffness last from the time you wake up?
A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h.
The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5.
FAS
Posted
Median
Inter-Quartile Range
Unit on scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.6(-2.8 to -0.1)
OG001-1.2(-2.8 to -0.4)
OG002-0.8(-2.1 to 1.0)
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
Wilcoxon rank-sum test
0.1241
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
-0.4
2-Sided
90
-1.0
0.2
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
Secondary
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
OG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
OG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
OG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Units
Counts
Participants
OG00040
OG00140
OG00239
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.0
OG00122.5
OG00223.1
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
Suissa-Shuster unconditional exact test
0.2639
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.
Risk Difference (RD)
7.5
2-Sided
90
-12.1
26.6
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Superiority or Other
2
40
21
40
EG001
Risankizumab 18 mg
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
0
40
21
40
EG002
Risankizumab 90 mg
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
2
39
22
39
EG003
Risankizumab 180 mg
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
2
40
22
40
EG004
Escape Low
Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either Placebo or risankizumab 18 mg at Day 1 of the DB treatment period
1
47
10
47
EG005
Escape High
Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either risankizumab 90 mg or risankizumab 180 mg at Day 1 of the DB treatment period
2
48
17
48
EG006
Escape
Patients who received escape treatments of risankizumab 180 mg regardless of the initial randomization group
3
95
27
95
EG007
Open Label Extension (OLE)
Patients who received 180 mg risankizumab (administered subcutaneously) every 8 weeks in OLE treatment period
1
26
11
26
EG008
Risankizumab High
Patients who received at least one risankizumab 90 mg or 180 mg treatment during the entire trial
9
138
85
138
EG009
Risankizumab Total
Patients who received at least one risankizumab treatment at any dose level
9
149
91
149
EG010
Total_all
All randomised patients
10
159
99
159
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0071 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Gastroenteritis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Incision site cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0080 affected138 at risk
EG0090 affected149 at risk
EG0101 affected159 at risk
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Sciatica
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
Confusional state
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0041 affected47 at risk
EG0050 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0081 affected138 at risk
EG0091 affected149 at risk
EG0101 affected159 at risk
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0083 affected138 at risk
EG0093 affected149 at risk
EG0103 affected159 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0021 affected39 at risk
EG0033 affected40 at risk
EG0041 affected47 at risk
EG0051 affected48 at risk
EG0062 affected95 at risk
EG0070 affected26 at risk
EG0088 affected138 at risk
EG0098 affected149 at risk
EG0108 affected159 at risk
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected40 at risk
EG0021 affected39 at risk
EG0034 affected40 at risk
EG0041 affected47 at risk
EG0051 affected48 at risk
EG0062 affected95 at risk
EG0070 affected26 at risk
EG0089 affected138 at risk
EG00911 affected149 at risk
EG01011 affected159 at risk
Bronchitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected40 at risk
EG0021 affected39 at risk
EG0033 affected40 at risk
EG0041 affected47 at risk
EG0051 affected48 at risk
EG0062 affected95 at risk
EG0070 affected26 at risk
EG0088 affected138 at risk
EG0098 affected149 at risk
EG0108 affected159 at risk
Gastroenteritis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected40 at risk
EG0021 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0072 affected26 at risk
EG0084 affected138 at risk
EG0095 affected149 at risk
EG0106 affected159 at risk
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected40 at risk
EG0022 affected39 at risk
EG0032 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0072 affected26 at risk
EG0086 affected138 at risk
EG0097 affected149 at risk
EG0108 affected159 at risk
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0004 affected40 at risk
EG0017 affected40 at risk
EG0027 affected39 at risk
EG0035 affected40 at risk
EG0045 affected47 at risk
EG0055 affected48 at risk
EG00610 affected95 at risk
EG0072 affected26 at risk
EG00830 affected138 at risk
EG00932 affected149 at risk
EG01033 affected159 at risk
Sinusitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0023 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0085 affected138 at risk
EG0095 affected149 at risk
EG0105 affected159 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0021 affected39 at risk
EG0032 affected40 at risk
EG0041 affected47 at risk
EG0051 affected48 at risk
EG0062 affected95 at risk
EG0072 affected26 at risk
EG0088 affected138 at risk
EG0098 affected149 at risk
EG0108 affected159 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0020 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0053 affected48 at risk
EG0063 affected95 at risk
EG0070 affected26 at risk
EG0085 affected138 at risk
EG0096 affected149 at risk
EG0106 affected159 at risk
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0083 affected138 at risk
EG0093 affected149 at risk
EG0103 affected159 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected40 at risk
EG0022 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0070 affected26 at risk
EG0085 affected138 at risk
EG0095 affected149 at risk
EG0107 affected159 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0050 affected48 at risk
EG0060 affected95 at risk
EG0071 affected26 at risk
EG0083 affected138 at risk
EG0093 affected149 at risk
EG0103 affected159 at risk
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected40 at risk
EG0021 affected39 at risk
EG0031 affected40 at risk
EG0041 affected47 at risk
EG0055 affected48 at risk
EG0066 affected95 at risk
EG0071 affected26 at risk
EG0088 affected138 at risk
EG0099 affected149 at risk
EG01011 affected159 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0086 affected138 at risk
EG0096 affected149 at risk
EG0108 affected159 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0003 affected40 at risk
EG0013 affected40 at risk
EG0022 affected39 at risk
EG0032 affected40 at risk
EG0042 affected47 at risk
EG0051 affected48 at risk
EG0063 affected95 at risk
EG0070 affected26 at risk
EG00810 affected138 at risk
EG00912 affected149 at risk
EG01012 affected159 at risk
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected39 at risk
EG0030 affected40 at risk
EG0041 affected47 at risk
EG0050 affected48 at risk
EG0061 affected95 at risk
EG0072 affected26 at risk
EG0083 affected138 at risk
EG0093 affected149 at risk
EG0103 affected159 at risk
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0084 affected138 at risk
EG0094 affected149 at risk
EG0104 affected159 at risk
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0003 affected40 at risk
EG0015 affected40 at risk
EG0023 affected39 at risk
EG0034 affected40 at risk
EG0042 affected47 at risk
EG0051 affected48 at risk
EG0063 affected95 at risk
EG0070 affected26 at risk
EG00814 affected138 at risk
EG00915 affected149 at risk
EG01017 affected159 at risk
Renal colic
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0030 affected40 at risk
EG0040 affected47 at risk
EG0051 affected48 at risk
EG0061 affected95 at risk
EG0070 affected26 at risk
EG0083 affected138 at risk
EG0093 affected149 at risk
EG0103 affected159 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0022 affected39 at risk
EG0031 affected40 at risk
EG0040 affected47 at risk
EG0052 affected48 at risk
EG0062 affected95 at risk
EG0072 affected26 at risk
EG0087 affected138 at risk
EG0097 affected149 at risk
EG0107 affected159 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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D013122
Spinal Diseases
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D000844
Ankylosis
D007592
Joint Diseases
D001168
Arthritis
113
40
-0.7
(-1.1 to -0.3)
OG000
OG002
Wilcoxon rank-sum test
0.1038
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
-0.3
2-Sided
90
-0.6
0.1
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
Wilcoxon rank-sum test
0.0101
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
-0.5
2-Sided
90
-0.7
-0.1
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
40
17.5
OG000
OG002
Suissa-Shuster unconditional exact test
0.0120
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Risk Difference (RD)
18.1
2-Sided
90
-0.8
35.3
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
Suissa-Shuster unconditional exact test
0.0465
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups
Risk Difference (RD)
12.5
2-Sided
90
-7.1
31.4
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
40
10.0
OG000
OG002
p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Risk Difference (RD)
0.1
2-Sided
90
-18.3
18.3
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Risk Difference (RD)
7.5
2-Sided
90
-12.1
26.6
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
40
32.5
OG000
OG002
Suissa-Shuster unconditional exact test
0.1243
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Risk Difference (RD)
13.3
2-Sided
90
-5.9
30.5
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
Suissa-Shuster unconditional exact test
0.1198
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups
Risk Difference (RD)
12.5
2-Sided
90
-7.1
31.4
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
40
-1.0
(-2.0 to -0.2)
OG000
OG002
Wilcoxon rank-sum test
0.3033
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
0.3
2-Sided
90
-0.5
1.0
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
Wilcoxon rank-sum test
0.3203
One sided p-value from Wilcoxon rank-sum test
Median estimate by Hodges-Lehmann method
-0.2
2-Sided
90
-0.8
0.4
The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 180 mg minus Placebo".
Superiority or Other
40
12.5
OG000
OG002
Suissa-Shuster unconditional exact test
0.2691
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.
Risk Difference (RD)
8.1
2-Sided
90
-10.9
25.7
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Superiority or Other
OG000
OG003
Suissa-Shuster unconditional exact test
0.4174
The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups
Risk Difference (RD)
-2.5
2-Sided
90
-21.8
17.0
The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".