Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bermekimab
JNJ-77474462 · 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 ...
JNJ-77474462 is an investigational small molecule being developed by Johnson & Johnson. It has been studied in Phase 1 clinical trials in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed. It is not approved for any indication and remains in clinical development.
JNJ-77474462 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored the Phase 1 clinical program for this small molecule candidate.
JNJ-77474462 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program has enrolled 102 participants in total across those completed studies.
JNJ-77474462 has been evaluated in two completed Phase 1 trials: NCT04544826, which studied single ascending subcutaneous doses in healthy participants of Japanese descent, and NCT04544813, which studied the drug in healthy participants. Both trials were conducted in Australia and have completed.
Yes. JNJ-77474462 is also known as bermekimab. The Phase 1 trial NCT04544826 refers to the drug as JNJ-77474462 (Bermekimab), confirming that the two names identify the same investigational asset.