A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis

NCT03496974 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018-PT044
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2 study of Bermekimab (MABp1) in patients with atopic dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment Emergent Adverse Events (TEAEs)

  Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.

  From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.

Secondary Outcomes (14)

• Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)

  Group A: Baseline to Week 4; Group B: Baseline to Week 7

• Pharmacokinetics (PK) Assessment at Week 7

  Group A: Week 4; Group B: Week 7

• Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7

  Group A: Week 4; Group B: Week 7

• Number of Patients Achieving ≥2 IGA Score Reduction at Week 7

  Group A: Week 4; Group B: Week 7

• Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7

  Group A: Baseline to Week 4; Group B: Baseline to Week 7

Study Arms (2)

Group A: 200 mg cohort

EXPERIMENTAL

The dose of bermekimab for Group A is 200 mg (2ml of the 100 mg/ml formulation)

Drug: Bermekimab Monoclonal Antibody 200 mg

Group B: 400 mg cohort

EXPERIMENTAL

The dose of bermekimab for Group B is 400 mg (2ml of the 200 mg/ml formulation) administered weekly by subcutaneous injection

Drug: Bermekimab Monoclonal Antibody 400 mg

Interventions

Bermekimab Monoclonal Antibody 200 mg DRUG

200 mg subcutaneous injection

Group A: 200 mg cohort

Bermekimab Monoclonal Antibody 400 mg DRUG

400 mg subcutaneous injection

Group B: 400 mg cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided by the patient
• Age 18 years or greater
• Chronic Atopic Dermatitis present for at least 3 years
• Disease is not responsive to topical medications, or for whom topical treatments are not indicated or desired.
• Willing and able to comply with all clinic visits and study-related procedures
• EASI score ≥16 at screening and baseline visits
• IGA score ≥3 at screening and baseline visits
• ≥10% body surface area (BSA) of AD involvement at screening and baseline visits
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable or undesired.

You may not qualify if:

• Treatment with an investigational drug within 8 weeks of baseline visit
• Having received the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
• Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy for AD
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit
• Initiation of treatment during the screening period with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
• Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
• History of severe allergic or anaphylactic reactions to monoclonal antibodies.
• Administration of any live (attenuated) vaccine within 4 weeks prior to the baseline.
• Any history of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis \[TB\], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
• Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
• Presence of skin comorbidities that may interfere with study assessments

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Florida Academic Centers Research & Education

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Ashley Otero, Corporate and Clinical Relations Manager
• Organization: XBiotech

aotero@xbiotech.com

512-386-2930

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 12, 2018
• Study Start: May 21, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 11, 2018
• Last Updated: March 12, 2021
• Results First Posted: July 30, 2019

Record last verified: 2021-02

Locations

US (1)