Clinical trial NCT03512275: A Study of Bermekimab in Patients With Hidradenitis Suppurativa
Official title: A Phase II, Open Label Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2 study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa.

Detailed description: Phase 2, open label study of bermekimab in patients with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of two patient groups, each of which will receive a total of 13 X 400mg weekly subcutaneous injections of bermekimab: Group A (n=10) patients who have failed anti-TNF therapy, and Group B (n=10) patients who have had no prior treatment with biological agents that block TNF.

Patients will be followed for 13 weeks to allow for assessment of safety and preliminary efficacy.

Additionally, patients who had received the 200 mg weekly subcutaneous injections of bermekimab under the previous version of this protocol are eligible to begin receiving the 400 mg dose starting with his/her next scheduled visit, and for the remainder of his/her treatment plan.

XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to Visit 14 (up to Day 93)
Secondary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Week 12
measure: Plasma Concentration of Bermekimab
timeFrame: Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13)
measure: Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in VAS Score for Pain
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Disease Activity Score (DAS) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Modified Sartorius Score (mSS)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Hospital Anxiety Depression Scale (HADS)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Gottlieb A, Natsis NE, Kerdel F, Forman S, Gonzalez E, Jimenez G, Hernandez L, Kaffenberger J, Guido G, Lucas K, Montes D, Gold M, Babcock C, Simard J. A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain. J Invest Dermatol. 2020 Aug;140(8):1538-1545.e2. doi: 10.1016/j.jid.2019.10.024. Epub 2020 Jan 29.