Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.

Official Title
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A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: CFZ533
* Drug: Placebo to CFZ533
* Drug: LYS006
* Drug: Placebo to LYS006
* Drug: MAS825
* Drug: Placebo to MAS825
* Drug: LOU064 25mg
* Drug: LOU064 100mg
* Drug: Placebo to LOU064
* Drug: VAY736
* Drug: Placebo to VAY736


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved Minimal body weight of 50 kg Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule Exclusion Criteria: Use of other investigational drugs at the time of screening or before Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception Pregnant or lactating women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CFZ533<br>s.c. | Drug: CFZ533<br>* s.c.<br>|
| Experimental: LYS006<br>p.o. | Drug: LYS006<br>* p.o.<br>|
| Placebo Comparator: Placebo to CFZ533<br>Matching placebo (s.c.) | Drug: Placebo to CFZ533<br>* s.c.<br>|
| Placebo Comparator: Placebo to LYS006<br>Matching placebo (p.o.) | Drug: Placebo to LYS006<br>* p.o.<br>|
| Experimental: MAS825<br>s.c. | Drug: MAS825<br>* s.c.<br>|
| Placebo Comparator: Placebo to MAS825<br>Matching placebo (s.c.) | Drug: Placebo to MAS825<br>* s.c.<br>|
| Active Comparator: LOU064 25mg<br>p.o. | Drug: LOU064 25mg<br>* p.o.<br>|
| Active Comparator: LOU064 100mg<br>p.o. | Drug: LOU064 100mg<br>* p.o.<br>|
| Placebo Comparator: Placebo to LOU064<br>Matching placebo p.o. | Drug: Placebo to LOU064<br>* p.o.<br>|
| Experimental: VAY736<br>s.c. | Drug: VAY736<br>* s.c.<br>|
| Placebo Comparator: Placebo to VAY736<br>Matching placebo (s.c.) | Drug: Placebo to VAY736<br>* s.c.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidradenitis Suppurativa Clinical Response (HiSCR) | Proportion of patients achieving clinical response after 16 weeks of treatment | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis suppurativa, acne inversa, platform study