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bermekimab

Phase 2

Hidradenitis Suppurativa | Monoclonal antibody | Dermatology |Johnson & Johnson|Trials Updated: Jul 27, 2023

bermekimab development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since Jul 2019

bermekimab target and mechanism

Molecular targetIL1A
Target classInhibitor
ModalityMonoclonal antibody

Also known as JNJ-77474462

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment255

FDA Designations

No designations recorded

bermekimab clinical trials

bermekimab · 3 trials · 4 indications

Phase 2 1Phase 1 2
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.

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Week 16

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants with Serious Adverse Events (SAEs)
Up to Week 16

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
Up to Week 16

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants with Clinically Significant Changes in Vital Signs
Up to Week 12

Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.

Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
Up to Week 12

Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.

Number of Participants with Clinically Significant Changes in Hematology
Up to Week 12

Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count \[RBS\], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.

Number of Participants with Clinically Significant Changes in Chemistry
Up to Week 12

Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.

Number of Participants with Clinically Significant Changes in Urinalysis
Up to Week 12

Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.

Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
Up to Week 12

Cmax is the maximum observed plasma concentration.

Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
Up to Week 12

AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.

Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462
Up to Week 12

AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.

Terminal Half-Life (T1/2) of JNJ-77474462
Up to Week 12

T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.

Absolute Subcutaneous (SC) Bioavailability (F%)
Up to Week 12

(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).

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
Cohort 1: JNJ-77474462 (Low Dose) or PlaceboEXPERIMENTALParticipants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
Cohort 2: JNJ-77474462 (Medium Dose) or PlaceboEXPERIMENTALParticipants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
Cohort 3: JNJ-77474462 (High Dose) or PlaceboEXPERIMENTALParticipants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
Cohort A: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 subcutaneously (SC).
Cohort B: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort C: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort D: JNJ-77474462 SC (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort E: JNJ-77474462 IV (Wave 1)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 intravenously (IV).
Cohort F: JNJ-77474462 SC (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort G: JNJ-77474462 SC (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 SC.
Cohort H: JNJ-77474462 IV (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 IV.
Cohort I: JNJ-77474462 IV (Wave 2)EXPERIMENTALParticipants will receive single dose of JNJ-77474462 IV.
Cohort J: Anakinra SCACTIVE_COMPARATORParticipants will receive a SC injection of anakinra once daily for 3 days.

Interventions

NameTypeDescription
bermekimabDRUGbermekimab 2 mL (200 mg/mL) pre-filled syringe
placeboDRUGplacebo 2 mL pre-filled syringe
JNJ-77474462DRUGJNJ-77474462 will be administered as SC injection.
AnakinraDRUGParticipants will receive a SC injection of anakinra 100 mg once daily for 3 days.
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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 StatesAustralia
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Frequently asked questions about bermekimab

What is bermekimab used for?

Bermekimab is being developed for hidradenitis suppurativa, a chronic inflammatory skin condition also known as acne inversa. It is an investigational monoclonal antibody and has been studied in a Phase 2 clinical trial in adults with the disease. It is not approved for any indication.

What does bermekimab target?

Bermekimab targets IL1A, also known as interleukin-1 alpha. It is a monoclonal antibody that acts as an inhibitor of this target. By binding IL1A, the drug is designed to interfere with the inflammatory signaling pathway implicated in hidradenitis suppurativa.

Who is developing bermekimab?

Bermekimab is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the clinical development of the drug in hidradenitis suppurativa.

What phase is bermekimab in?

Bermekimab is in Phase 2 clinical development. It has completed one Phase 2 trial in hidradenitis suppurativa. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is bermekimab in?

Bermekimab has been evaluated in a completed Phase 2 trial, NCT04019041, titled A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa. The trial enrolled 153 adults in the United States and was randomized, double-blind, and placebo-controlled.