PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
Official Title
A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE
Acronym
PRELUDE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2023
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
Jul 27, 2020Actual
Primary Completion Date
Nov 16, 2021Actual
Completion Date
May 3, 2022Actual
First Submitted Date
Jan 8, 2020
First Submission Date that Met QC Criteria
Mar 5, 2020
First Posted Date
Mar 9, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 5, 2023
Results First Submitted that Met QC Criteria
Jul 28, 2023
Results First Posted Date
Aug 22, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 18, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Aug 22, 2023Actual
Last Update Submitted Date
Jul 28, 2023
Last Update Posted Date
Aug 22, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.
Detailed Description
This was a 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial which assessed the efficacy and safety of secukinumab 300 mg in two different dosing regimens: every 4 weeks (Q4W) and every 2 weeks (Q2W) in approximately 111 patients with biopsy-proven forms of lichen planus.
There was a screening period (up to 4 weeks prior to baseline), a treatment period 1 (baseline to Week 16), a treatment period 2 (Week 16 to Week 32) and a follow-up period (8 weeks after Week 32).
Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients
Drug: secukinumab 300 mg Q4W
Cutaneous lichen planus placebo
Placebo Comparator
Placebo in 1ml PFS in cutaneous lichen patients
Other: Placebo
Mucosal lichen planus secukinumab 300 mg Q4W
Experimental
Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.
Drug: secukinumab 300 mg Q4W
Mucosal lichen planus placebo
Placebo Comparator
Placebo 1 ml PFS in mucosal lichen planus patients
Other: Placebo
Lichen planopilaris secukinumab 300 mg Q4W
Experimental
Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.
Drug: secukinumab 300 mg Q4W
Lichen planopilaris placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
secukinumab 300 mg Q4W
Drug
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
Cutaneous lichen planus secukinumab 300mg Q4W
Lichen planopilaris secukinumab 300 mg Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.
Baseline up to week 16
Secondary Outcomes
Measure
Description
Time Frame
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Female and male patients ≥ 18 years of age.
Subjects must have biopsy-confirmed forms of cutaneous lichen planus (CLP), mucosal lichen planus (MLP), or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria:
rated IGA of ≥ 3 (moderate or severe) AND
inadequate response to topical corticosteroids of high-ultrahigh potency in the opinion of the investigator.
If using any of the allowed topical treatments on the affected areas, the dose and application frequency should remain stable for 2 weeks prior to randomization and until Week 16.
Exclusion Criteria:
Clinical history suspicious for lichenoid drug eruption.
Lichen planus pigmentosus.
Clinical picture or history suspicious of paraneoplastic mucosal lichen planus.
Subjects whose lichen planus is a predominantly bullous variant.
Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube.
Clinical picture of scarring alopecia without active inflammation.
Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocque).
Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
Clinical picture of LPP in patients who have already failed 3 or more systemic immunosuppressive or immunomodulatory agents (e.g. systemic steroids, hydroxychloroquine, cyclosporine, methotrexate and mycophenolate mofetil).
Currently enrolled in any other clinical trial involving any investigational agent or device.
Previous exposure to any other biologic drug directly targeting IL-17A or IL-17RA (e.g. secukinumab, ixekizumab or brodalumab) or IL-23/p19 (e.g. tildrakizumab, guselkumab, risankizumab).
Diagnosis of active infectious diseases of the skin, scalp or mucosa (for example bacterial, viral or fungal infections of the mouth) that may interfere with the assessment of the study disease or require treatment with prohibited medications.
Diagnosis of active inflammatory diseases of the skin, scalp or mucosa other than lichen planus that may interfere with the assessment of the study disease or require treatment with prohibited medications.
Presence of any other skin condition that may affect the evaluations of the study disease.
Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) and/or presence of laboratory abnormalities which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Mahon-Smith A, Skingley G, Ayala-Nunes L, Batish A, Sharp R, Naujoks C, Schruf E, Compagno N, Moreno SG. Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus. Dermatol Ther (Heidelb). 2023 Nov;13(11):2817-2837. doi: 10.1007/s13555-023-00990-4. Epub 2023 Oct 5.
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
163 subjects (3 cohorts) were screened and 111 were randomized. Subjects in the AIN457 300 mg Q4W group in TP1 continued on AIN457 300mg Q4W in TP2. Subjects in the Placebo group in TP1 received AIN457 300mg Q2W in TP2. Patients in the Placebo group with spontaneous remission at Week 16 entered the Follow-up period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
FG001
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - CLP Cohort
Periods
Title
Milestones
Reasons Not Completed
Treatment Period 1: Baseline to 16 Weeks
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Oct 26, 2020
Apr 5, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
PoC study, 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of secukinumab 300 mg in two different dosing regimens in 108 patients with biopsy-proven forms of lichen planus.
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS)
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS)
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period
REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease.
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period
OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity.
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS)
The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity
Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)
Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life.
Baseline, Week 16 and Week 32
Thousand Oaks
California
91320
United States
Novartis Investigative Site
Cromwell
Connecticut
06416
United States
Novartis Investigative Site
Jacksonville
Florida
32224
United States
Novartis Investigative Site
Miami
Florida
33125
United States
Novartis Investigative Site
Snellville
Georgia
30078
United States
Novartis Investigative Site
Omaha
Nebraska
68144
United States
Novartis Investigative Site
Las Vegas
Nevada
89128
United States
Novartis Investigative Site
East Windsor
New Jersey
08520
United States
Novartis Investigative Site
Forest Hills
New York
11375
United States
Novartis Investigative Site
New York
New York
10025 1737
United States
Novartis Investigative Site
Portland
Oregon
97223
United States
Novartis Investigative Site
Charleston
South Carolina
29407
United States
Novartis Investigative Site
Houston
Texas
77030
United States
Novartis Investigative Site
Pflugerville
Texas
78660
United States
Novartis Investigative Site
Bordeaux
33075
France
Novartis Investigative Site
Chambray-lès-Tours
37170
France
Novartis Investigative Site
Lyon
69437
France
Novartis Investigative Site
Marseille
13885
France
Novartis Investigative Site
Nantes
44093
France
Novartis Investigative Site
Nice
06202
France
Novartis Investigative Site
Paris
75475
France
Novartis Investigative Site
Rouen
76031
France
Novartis Investigative Site
Toulouse
31400
France
Novartis Investigative Site
Aachen
52074
Germany
Novartis Investigative Site
Berlin
13353
Germany
Novartis Investigative Site
Bramsche
49565
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Halle
06120
Germany
Novartis Investigative Site
Hamburg
20354
Germany
Novartis Investigative Site
Lübeck
23538
Germany
Novartis Investigative Site
Marburg
35039
Germany
Novartis Investigative Site
München
81377
Germany
Novartis Investigative Site
Würzburg
97080
Germany
Mahon-Smith A, Clifford M, Batish A, Sharp R, Panter C, Naujoks C, Schruf E, Compagno N, Moreno SG. Patient Experience of Lichen Planus: A Qualitative Exploration of Signs, Symptoms, and Health-Related Quality of Life Impacts. Dermatol Ther (Heidelb). 2023 Sep;13(9):2001-2017. doi: 10.1007/s13555-023-00968-2. Epub 2023 Jul 28.
Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.
Placebo in TP1. Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe
FG002
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
FG003
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - MLP Cohort
Placebo in TP1. Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe
FG004
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
FG005
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - LPP Cohort
Placebo in TP1. Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe
FG00025 subjects
FG00112 subjects
FG00224 subjects
FG00313 subjects
FG00424 subjects
FG00513 subjects
Placebo Responder
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00023 subjects
FG00110 subjects
FG00224 subjects
FG00313 subjects
FG00423 subjects
FG00512 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Type
Comment
Reasons
Progressive disease
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject/guardian decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period 2: 16 to 32 Weeks
Type
Comment
Milestone Data
STARTED
FG00022 subjects
FG0018 subjects
FG00223 subjects
FG00311 subjects
FG00423 subjects
FG00512 subjects
COMPLETED
FG00017 subjects
FG0017 subjects
FG00219 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AIN457 300 mg Q4W - TP 1 - CLP Cohort
AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
BG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
BG002
AIN457 300 mg Q4W - TP 1 - MLP Cohort
AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
BG003
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
BG004
AIN457 300 mg Q4W - TP 1 - LPP Cohort
AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
BG005
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00112
BG00224
BG00313
BG00424
BG00513
BG006111
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
18 to <65 years
Title
Measurements
BG00022
BG0019
BG00214
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG0018
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian (Indian)
Title
Measurements
BG0000
BG0010
BG002
Baseline of Investigator's Global Assessment (IGA)
The IGA provides a harmonized, 5-point grading system to assess disease severity for subjects of all 3 subtypes entering the study. The predominant subtype alone defined the IGA score of the subject and was collected separately for concomitant subtypes, if present (0=clear, 1=minimal, 2=mild, 3=moderate, 4=severe).
Count of Participants
Participants
Title
Denominators
Categories
0=Clear
Title
Measurements
BG0000
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
Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.
Full analysis set of participants with a baseline IGA score >= 3 were included
Posted
Median
95% Confidence Interval
percentage of participants
Baseline up to week 16
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 - CLP Cohort
AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
OG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
AIN457 300 mg Q4W - TP 1 - MLP Cohort
AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
OG003
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG004
AIN457 300 mg Q4W - TP 1 - LPP Cohort
AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe
OG005
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Units
Counts
Participants
OG00025
OG00112
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG00044.0(25.8 to 63.32)
OG00158.2(31.0 to 82.6)
OG00237.5(20.3 to 57.2)
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
Posterior median difference
-13.9
2-Sided
95
-44.8
19.3
Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo
Other
OG002
OG003
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Placebo to AIN457 300 mg Q2W - TP 2 - CLP Cohort
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Placebo to AIN457 300 mg Q2W - TP 2- LPP Cohort
Secondary
Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS)
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS)
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Count of Participants
Participants
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Count of Participants
Participants
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2- MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Count of Participants
Participants
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period
REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Placebo to AIN457 300 mg Q2W TP 2 - MLP Cohort
Secondary
Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period
OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Secondary
Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS)
The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
OG002
Secondary
Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)
Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life.
Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 16 and Week 32
ID
Title
Description
OG000
AIN457 300 mg Q4W - TP 1 and TP 2 -LPP Cohort
AIN457 300 mg every 4 weeks administered via a pre-filled syringe. Participants on AIN457 in TP 1 for 16 weeks continued AIN457 in TP 2 for 16 weeks.
OG001
Placebo - TP 1 - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
Time Frame
Adverse events were reported from first dose of study treatment up to a maximum of 300 days which included an approximate follow up period of 8 weeks for AIN457 treatment groups.
Description
"Any AIN457 300 mg Q4W" Arm/Group Total Number at Risk represents all participants who were assigned AIN457 300 mg Q4W for a given cohort during the study. Participants who were on placebo in Treatment Period 1 who continued into Treatment Period 2 received AIN457 300 mg Q2W.
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
AIN457 300 mg Q4W - CLP Cohort
AIN457 300 mg every 4 weeks up to 32 weeks administered via a pre-filled syringe
0
25
0
25
15
25
EG001
Placebo - CLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
0
12
1
12
7
12
EG002
Any AIN457 300 mg - CLP Cohort
AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe
0
33
0
33
21
33
EG003
Placebo to AIN457 300 mg Q2W - CLP Cohort
Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
0
8
0
8
6
8
EG004
AIN457 300 mg Q4W - MLP Cohort
AIN457 300 mg every 4 weeks up to 32 weeks administered via a pre-filled syringe
0
24
1
24
18
24
EG005
Placebo - MLP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
0
13
0
13
8
13
EG006
Any AIN457 300 mg - MLP Cohort
AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe
0
35
2
35
26
35
EG007
Placebo to AIN457 300 mg Q2W - MLP Cohort
Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
0
11
1
11
8
11
EG008
AIN457 300 mg Q4W - LPP Cohort
AIN457457 300 mg every 4 weeks up to 32 weeks administered via a pre-filled syringe
0
24
0
24
16
24
EG009
Placebo - LPP Cohort
Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe
0
13
1
13
7
13
EG010
Any AIN457 300 mg - LPP Cohort
AIN457 300mg administered every 4 weeks or every 2 weeks via a pre-filled syringe
0
36
1
36
22
36
EG011
Placebo to AIN457 300 mg Q2W - LPP Cohort
Placebo non-responders during TP 1 received AIN457 300 mg every 2 weeks from Week 16 to Week 32 in TP 2 via a pre-filled syringe.
0
12
1
12
6
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG0030 affected8 at risk
EG0040 affected24 at risk
EG0050 affected13 at risk
EG0060 affected35 at risk
EG0070 affected11 at risk
EG0080 affected24 at risk
EG0091 affected13 at risk
EG0100 affected36 at risk
EG0110 affected12 at risk
Colitis ulcerative
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymph node pain
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG0030 affected8 at risk
EG0040 affected24 at risk
EG0050 affected13 at risk
EG0060 affected35 at risk
EG0070 affected11 at risk
EG0080 affected24 at risk
EG0090 affected13 at risk
EG0100 affected36 at risk
EG0110 affected12 at risk
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Auricular swelling
Ear and labyrinth disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Dry eye
Eye disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected12 at risk
EG0023 affected33 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected12 at risk
EG0022 affected33 at risk
EG003
Leukoplakia oral
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Asthenia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0021 affected33 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Oedema peripheral
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Peripheral swelling
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected12 at risk
EG0022 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected25 at risk
EG0010 affected12 at risk
EG0023 affected33 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0022 affected33 at risk
EG003
Cystitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Ear infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Furuncle
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Herpes ophthalmic
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected12 at risk
EG0022 affected33 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Post-acute COVID-19 syndrome
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Superinfection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0021 affected33 at risk
EG003
Tongue fungal infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0011 affected12 at risk
EG0021 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected25 at risk
EG0010 affected12 at risk
EG0023 affected33 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Syncope
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Micturition disorder
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0021 affected33 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0003 affected25 at risk
EG0011 affected12 at risk
EG0024 affected33 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0011 affected12 at risk
EG0020 affected33 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 affected25 at risk
EG0010 affected12 at risk
EG0020 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0002 affected25 at risk
EG0010 affected12 at risk
EG0022 affected33 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
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.