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Recruiting NCT07287644

A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

Phase II / Phase III Interventional Hidradenitis Suppurativa (HS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BFB759, Placebo for BFB759.
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Canada, Czechia, Germany +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Dose Ranging, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of BFB759 in Patients With Moderate to Severe Hidradenitis Suppurativa

Overview

This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.

Interventions

  • Biological BFB759
    BFB759 is a human mAb that inhibits multiple pro-inflammatory cytokines that contribute to the pathogenesis of multiple disease processes characterized by aberrant inflammation, including hidradenitis suppurativa.
  • Other Placebo for BFB759
    Placebo for BFB759

Primary outcome measures

  • Efficacy of BFB759 in HS [Time frame: Baseline to Week 16 and baseline to Week 32]
Secondary outcome measures (5)
  • Evaluate the clinical activity of BFB759 using HiSCR50 [Time frame: Baseline to Week 16 and baseline to Week 32]
  • Evaluate the safety/tolerability of BFB759 [Time frame: routinely over 21 months (about 22 visits during the course of study)]
  • To evaluate the clinical activity of BFB759 using the International Hidradenitis Suppurativa Severity Score System (IHS4) [Time frame: Baseline to Week 16 and baseline to Week 32]
  • To evaluate the clinical activity of BFB759 using the Skin Pain Numerical Rating Scale (NRS) [Time frame: Baseline to Week 16 and baseline to Week 32]
  • To evaluate the clinical activity of BFB759 using the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA) [Time frame: Baseline to Week 16 and baseline to Week 32]

Eligibility criteria

Inclusion criteria

  • Are adults (18 to 75 years) with a diagnosis of hidradenitis suppurativa for at least one year.
  • Have moderate to severe disease not well controlled by systemic antibiotic treatment.
  • Are willing to follow study instructions, attend regular visits, and avoid certain other medications during the study.

Exclusion criteria

  • Have certain infections or other immune conditions.
  • Recently used medications that could interfere with the study.
  • Are pregnant or breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 31 centers
  • Saguaro Dermatology — Phoenix
  • Encino Research Center — Encino
  • Clinical Science Institute — Santa Monica
  • Skin Care Research — Boca Raton
  • Center for Skin Science and Innovation — Fort Lauderdale
  • Ziaderm Research LLC — North Miami Beach
  • Clinical Trials Management, LLC — Tampa
  • DelRicht Research — Atlanta
  • … and 23 more centers
Germany · 6 centers
  • St. Josef-Hospital Bochum — Bochum
  • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie — Frankfurt
  • University Clinic Dermatology Heidelberg — Heidelberg
  • University Hospital, Leipzig — Leipzig
  • University of Luebeck — Lübeck
  • Klinik und Poliklinik fur Dermatologie und Allergologie — Munich
Spain · 6 centers
  • Hospital Universitario Virgen De Las Nieves — Granada
  • Hospital Asil de Granollers — Granollers
  • Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria
  • Hospital Gregorio Maranon — Madrid
  • Complejo Hospitalario Universitario de Pontevedra — Pontevedra
  • Hospital de Manises — Valencia
Bulgaria · 5 centers
  • Medical Center Medconsult Burgas EOOD — Burgas
  • Medical Center Medconsult Pleven-Lovech Branch — Lovech
  • Medical Center Medconsult Pleven OOD — Pleven
  • Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD — Plovdiv
  • Medical Center Rusemed — Rousse
Poland · 5 centers
  • NZOZ Specjal. Osrodek Dermatologiczny DERMAL — Bialystok
  • Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska — Lublin
  • Melita Medical — Wroclaw
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu — Wroclaw
  • Wojewódzki Szpital Specjalistyczny we Wrocławi,Oddział Dermatologiczny — Wroclaw
Czechia · 3 centers
  • CCR Ostrava s.r.o. — Ostrava
  • Pratia Pardubice a.s. — Pardubice
  • Sanatorium of Professor Arenbergera — Prague
Canada · 2 centers
  • York Dermatology Clinical and Research Centre — Richmond Hill
  • North York Research Inc. — Toronto

Identifiers

NCT: NCT07287644 · CL-BFB759-003 · COMPASS 2-HS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗