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bermekimab

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Jul 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04019041A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis SuppurativaPHASE2 COMPLETED 153Sep 16, 2019Nov 17, 2020Jul 27, 202333 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Week 12

HiSCR was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

Secondary Endpoints
Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
Baseline, Week 12, Week 16
Change Form Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Weeks 12 and 16
Baseline, Week 12, Week 16
Change From Baseline in Number of Draining Fistulas at Weeks 12 and 16
Baseline, Week 12, Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
bermekimab ewEXPERIMENTAL2 800 mg bermekimab loading dose subcutaneous injections, followed by weekly 400 mg bermekimab injections
bermekimab eowEXPERIMENTAL2 800 mg loading dose subcutaneous injections, followed by alternating weekly 400 mg bermekimab injections with matching placebo injections
placebo ewPLACEBO_COMPARATOR2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections
Interventions
NameTypeDescription
bermekimabDRUGbermekimab 2 mL (200 mg/mL) pre-filled syringe
placeboDRUGplacebo 2 mL pre-filled syringe
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Written informed consent provided by the participant * Male or female, age greater than or equal to (\>=) 18 years * Naïve to OR failure of prior targeted biologic therapy for Hidradenitis Suppurativa (HS) (including anti-TNF, anti-IL-17, or JAK inhibitor therapy) * Diagnosis ...

Countries:United States
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