Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-77474462
bermekimab · 3 trials · 4 indications
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.
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.
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.
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 (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
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 (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 (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
Cmax is the maximum observed plasma concentration.
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.
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.
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
(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 (%).
| Arm | Type | Description |
|---|---|---|
| bermekimab ew | EXPERIMENTAL | 2 800 mg bermekimab loading dose subcutaneous injections, followed by weekly 400 mg bermekimab injections |
| bermekimab eow | EXPERIMENTAL | 2 800 mg loading dose subcutaneous injections, followed by alternating weekly 400 mg bermekimab injections with matching placebo injections |
| placebo ew | PLACEBO_COMPARATOR | 2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections |
| Cohort 1: JNJ-77474462 (Low Dose) or Placebo | EXPERIMENTAL | Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection. |
| Cohort 2: JNJ-77474462 (Medium Dose) or Placebo | EXPERIMENTAL | Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection. |
| Cohort 3: JNJ-77474462 (High Dose) or Placebo | EXPERIMENTAL | Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection. |
| Cohort A: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 subcutaneously (SC). |
| Cohort B: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort C: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort D: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort E: JNJ-77474462 IV (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 intravenously (IV). |
| Cohort F: JNJ-77474462 SC (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort G: JNJ-77474462 SC (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort H: JNJ-77474462 IV (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 IV. |
| Cohort I: JNJ-77474462 IV (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 IV. |
| Cohort J: Anakinra SC | ACTIVE_COMPARATOR | Participants will receive a SC injection of anakinra once daily for 3 days. |
| Name | Type | Description |
|---|---|---|
| bermekimab | DRUG | bermekimab 2 mL (200 mg/mL) pre-filled syringe |
| placebo | DRUG | placebo 2 mL pre-filled syringe |
| JNJ-77474462 | DRUG | JNJ-77474462 will be administered as SC injection. |
| Anakinra | DRUG | Participants will receive a SC injection of anakinra 100 mg once daily for 3 days. |
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 ...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
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.
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.
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.
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.
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.