Moderate to Severe Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Be a male or female 18 years of age or older. 2. Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. 3. Have HS for at least 1 year prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history. 4. Have HS lesions present in at least 2 distinct anatomic areas. 5. Have Hurley Stage II or Hurley Stage III HS as determined by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 275 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 2. Has unstable cardiovascular disease or a cardiac hospitalization within the last 3 months. 3. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly. 4. A history of malignancy within 5 years. 5. Has a history of chronic or recurrent infectious disease, chronic chest infection, recurrent urinary tract infection, fungal infection, or open, draining, or infected skin wounds or ulcers (not related to HS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-response of bermekimab efficacy in participants with moderate to severe HS;Secondary Objective: - To evaluate the clinical efficacy of bermekimab in participants with moderate to severe HS. - To characterize additional patient-reported outcome efficacy measures of bermekimab in participants with moderate to severe HS. - To assess the safety and tolerability of bermekimab in participants with moderate to severe HS. - To evaluate the pharmacokinetics (PK) and immunogenicity of bermekimab in participants with moderate to severe HS.;Primary end point(s): Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50);Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of participants achieving HiSCR75 and HiSCR90. 2) Change from baseline in the abscess and inflammatory nodule (AN) count. 3) Proportion of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count. 4) Proportion of participants achieving an AN count of 0/1 and 0/1/2. 5) Proportion of participants achieving complete elimination of abscesses at Week 16 among those participants with abscesses. 6) Change in the number of abscesses. 7) Proportion of participants achieving complete elimination of draining fistulas at Week 16 among those participants with draining fistulas at baseline. 8) Change in number of draining fistulas. 9) Proportion of participants achieving complete elimination of inflammatory nodules at Week 16 among those participants with inflammatory nodules. 10) Change in number of inflammatory nodules. 11) Change of International Hidradenitis Suppurativa Severity Score System (IHS4) score. 12) Proportion of participants with HS-Investigator’s Global Assessment (HS-IGA) score of inactive (0), almost inactive (1), or mild (2) and with at least 2-grade improvement. 13) Proportion of participants with HS-IGA score of inactive (0) or almost inactive (1) among participants with HS-IGA score of moderate (3) or severe (4).;Timepoint(s) of evaluation of this end point: Numbers below correspond to section E.5.2. - To Week 16: 1, 3-5, 7, 9, 13 - From baseline to Week 16: 6, 8, 10-12 - At week 16: 2 | — |
Countries
Australia, Germany, Japan, Netherlands, Poland, United States
Contacts
Public ContactJBBV Clinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed