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bermekimab

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

bermekimab · 1 trial · 3 indications

Phase 2 1
NCT04019041A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED153 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

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 to 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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Frequently asked questions about bermekimab

What is bermekimab used for?

Bermekimab is an investigational small molecule being developed for the treatment of hidradenitis suppurativa, also known as acne inversa. It is intended for patients with this chronic inflammatory skin condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes bermekimab?

Bermekimab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 2 clinical development for hidradenitis suppurativa.

What phase is bermekimab in?

Bermekimab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of hidradenitis suppurativa, a chronic inflammatory skin condition.

What clinical trials is bermekimab in?

Bermekimab has one completed Phase 2 clinical trial, identified as NCT04019041. This study evaluated the efficacy, safety, and tolerability of bermekimab in patients with hidradenitis suppurativa. The trial enrolled 153 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is bermekimab the same as any other drug?

Bermekimab is not known to have any alternative names. It is a distinct investigational small molecule being developed by Johnson & Johnson for the treatment of hidradenitis suppurativa. The drug is currently in Phase 2 clinical development.