Phase 2
N=42
A Study of Bermekimab in Patients With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT03512275 ↗Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Adverse Events — 21; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bermekimab Monoclonal Antibody 400 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
21; 16 | — |
| SECONDARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 |
62.5; 61.1 | — |
| SECONDARY Plasma Concentration of Bermekimab |
32.7; 36.7; 37.4; 42.2; 36.3; 48.0 | — |
| SECONDARY Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease |
3.11; 3.71 | — |
| SECONDARY Change From Baseline to Week 12 in VAS Score for Pain |
4.07; 5.01 | — |
| SECONDARY Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score |
7.03; 11.52 | — |
| SECONDARY Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score |
0.81; 1.97 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS) at Week 12 |
35.56; 63.84 | — |
| SECONDARY Change From Baseline to Week 12 in Modified Sartorius Score (mSS) |
— | — |
| SECONDARY Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count |
6.44; 3.97 | — |
| SECONDARY Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS) |
3.11; 1.33; 1.39; 0.54 | — |
Summary
Phase 2 study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa.
Eligibility Criteria
Inclusion Criteria
- Written informed consent provided by the patient.
- Male or female, age 18 years or greater.
- For group A, patients must have received and failed anti-TNF therapy.
- For Group B, patients must not have received any prior treatment with any anti-TNF therapy.
- Patients who have received 200 mg dose of bermekimab in this study (previous version(s)) are eligible to begin receiving 400 mg dose starting with the patient's next scheduled visit for the remainder of his/her treatment plan.
- Diagnosis of HS for at least 1 year prior to screening.
- HS affecting at least two distinct anatomic areas, one of which is Hurley II or III stage.
- A total body count of abscesses and inflammatory nodules (AN) of at least 3
- Full understanding of the procedures of the study protocol and willingness to comply with them.
- In case of female patients of childbearing potential, willingness to use one method of contraception of high efficacy during the entire study period. This method can be intake of hormonal contraceptives or the use of one of the following: condoms, diaphragm or an intrauterine device. Women of non-childbearing potential include those considered to have a medical history that indicates that pregnancy is not a reasonable risk, including post-menopausal women and those with a history of hysterectomy.
Exclusion Criteria
- Age below 18 years.
- Receipt of oral antibiotic treatment for HS within 28 days prior to screening.
- Receipt of prescription topical therapies for the treatment of HS within 14 days prior to screening, and/or systemic therapies for HS (immunosuppressants, corticosteroids, retinoids, or hormonal therapies) within 28 days prior to screening.
- History of treatment with bermekimab for any reason, EXCEPT patients previously treated with 200 mg bermekimab dose in the previous version(s) of this study.
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
- Has received a live (attenuated) vaccine over the 4 weeks prior to screening.
- New intake of opioid analgesics starting within 14 days prior to screening.
- Major surgery (requiring general anesthesia or respiratory assistance) within 28 days prior to Visit 1, Day 0 of start of study drug.
- Hepatic dysfunction defined as any value of transaminases or of γ-glutamyl transpeptidase (γGT), or of total bilirubin > 3 x upper normal limit
- Stage C Child-Pugh liver cirrhosis.
- Chronic infection by the human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
- Neutropenia defined as <1,000 neutrophils/mm3.
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT03512275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.