Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Официальное название

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa

Обзор

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Вмешательства

• Препарат Brivekimig
  * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
• Препарат Placebo
  * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Первичные конечные точки

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Срок оценки: Up to Week 16]

Вторичные конечные точки (10)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Срок оценки: Up to Week 16]
• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [Срок оценки: Up to Week 16]
• Change from Baseline in draining tunnel count at Week 16. [Срок оценки: From Baseline to Week 16]
• Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16 [Срок оценки: From Baseline to Week 16]
• Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8 [Срок оценки: From Baseline to Week 8]
• Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16. [Срок оценки: From Baseline to Week 16]
• Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16. [Срок оценки: From Baseline to Week 16]
• Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies. [Срок оценки: Up to End of Study (approximately 60 weeks)]
• Serum brivekimig concentration throughout the study. [Срок оценки: Up to End of Study (approximately 60 weeks)]
• Incidence of treatment-emergent (TE) anti-drug antibody responses. [Срок оценки: Up to End of Study (approximately 60 weeks)]

Критерии участия

Критерии включения

• Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
• Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
• Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
• Participants must be either biologic-naive or biologic-experienced.
• Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.
• Participant must have a draining tunnel count of ≤20 at the Baseline visit.

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
• History of recurrent or recent serious infection
• Known history of significant immunosuppression
• History of solid organ transplant or stem cell transplant
• History of splenectomy
• History of moderate to severe congestive heart failure.
• History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
• Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
• History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
• Active suicidality and therefore significant suicide risk, as judged by the Investigator
• A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Medical Dermatology Specialists - Site Number: 8400019 — Phoenix
• Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014 — Scottsdale
• Northridge Clinical Trials - Northridge- Site Number : 8400005 — Northridge
• FXM Clinical Research - Miami- Site Number : 8400017 — Miami
• FXM Clinical Research - Miramar- Site Number : 8400004 — Miramar
• Advanced Medical Research - Atlanta- Site Number : 8400011 — Atlanta
• Georgia Skin & Cancer Clinic- Site Number : 8400009 — Savannah
• The Iowa Clinic West Des Moines Campus- Site Number : 8400007 — West Des Moines
• … и ещё 7 центров

Германия · 7 центров

• Investigational Site Number : 2760002 — Bochum
• Investigational Site Number : 2760008 — Bramsche
• Investigational Site Number : 2760003 — Frankfurt
• Investigational Site Number : 2760005 — Kiel
• Investigational Site Number : 2760004 — Mainz
• Investigational Site Number : 2760001 — Münster
• Investigational Site Number : 2760006 — Würzburg

Испания · 7 центров

• Investigational Site Number: 7240006 — Santiago de Compostela
• Investigational Site Number: 7240003 — Las Palmas de Gran Canaria
• Investigational Site Number: 7240002 — Manises
• Investigational Site Number: 7240004 — Cadiz
• Investigational Site Number : 7240007 — Granada
• Investigational Site Number: 7240005 — Madrid
• Investigational Site Number: 7240001 — Madrid

Канада · 6 центров

• Investigational Site Number : 1240008 — Edmonton
• Interior Dermatology Centre - Site Number: 1240003 — Kelowna
• Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc. — Hamilton
• Investigational Site Number : 1240009 — Toronto
• Investigational Site Number: 1240005 — Québec
• Park Dermatology - Site number: 1240007 — Sherwood Park

Франция · 6 центров

• Investigational Site Number: 2500001 — Antony
• Investigational Site Number: 2500004 — Bezannes
• Investigational Site Number : 2500003 — Bordeaux
• Investigational Site Number : 2500002 — Lyon
• Investigational Site Number : 2500006 — Saint-Priest-en-Jarez
• Investigational Site Number: 2500007 — Toulouse

Чили · 4 центра

• Investigational Site Number: 1520003 — Santiago
• Investigational Site Number: 1520002 — Santiago
• Investigational Site Number: 1520001 — Santiago
• Investigational Site Number: 1520005 — Santiago

Китай · 4 центра

• Investigational Site Number : 1560002 — Чэнду
• Investigational Site Number : 1560001 — Гуанчжоу
• Investigational Site Number : 1560004 — Шанхай
• Investigational Site Number : 1560005 — Ürümqi

Чехия · 4 центра

• Investigational Site Number: 2030002 — Ostrava
• Investigational Site Number: 2030003 — Ostrava
• Investigational Site Number: 2030001 — Prague
• Investigational Site Number: 2030004 — Prague

Греция · 4 центра

• Investigational Site Number : 3000002 — Athens
• Investigational Site Number : 3000001 — Athens
• Investigational Site Number : 3000005 — Athens
• Investigational Site Number : 3000004 — Thessaloniki

Венгрия · 3 центра

• Site Number: 3480001 — Debrecen
• Investigational Site Number: 3480003 — Pécs
• Investigational Site Number : 3480004 — Székesfehérvár

Израиль · 3 центра

• Investigational Site Number : 3760003 — Haifa
• Investigational Site Number: 3760002 — Jerusalem
• Investigational Site Number: 3760001 — Tel Aviv

Италия · 3 центра

• Investigational Site Number: 3800002 — Milan
• Investigational Site Number : 3800001 — Catania
• Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004 — Roma

Япония · 3 центра

• Meiwa Hospital — Nishinomiya
• University of the Ryukyus Hospital - Site Number: 3920002 — Nishihara
• Nihon University Itabashi Hospital — Tokyo

Польша · 3 центра

• Investigational Site Number: 6160001 — Wroclaw
• Investigational Site Number: 6160003 — Lodz
• Investigational Site Number: 6160002 — Warsaw

Австралия · 2 центра

• Investigational Site Number: 0360001 — Liverpool
• Alfred Hospital - Site Number: 0360002 — Melbourne

Великобритания · 2 центра

• Investigational Site Number : 8260008 — London
• Investigational Site Number : 8260006 — Leeds

Нидерланды · 1 центр

• Investigational Site Number : 5280002 — Groningen

Пуэрто-Рико · 1 центр

• Grupo Dermatologico de Carolina- Site Number : 8400023 — Carolina

ОАЭ · 1 центр

• Investigational Site Number : 7840001 — Abu Dhabi

Идентификаторы

NCT: NCT07170917 · DRI19220 · 2025-522333-61-00 · U1111-1318-3453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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