Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Hidradenitis Suppurativa
Спонсор: Merck Sharp & Dohme LLC
Налично на:
БГ
Обобщение
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
Описание
This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.
Кой може да участва
Inclusion Criteria:
* Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
* Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
* Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
* Has ≤20 draining tunnel count at Screening and Randomization
Exclusion Criteria:
* Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
* Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
* Has a transplanted organ and requires continued systemic immunosuppression
* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years
* Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
* Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Has any active infection
* Has active tuberculosis
* Has had major surgery within the past 3 months or has a major surgery planned during the study
* Has a history of clinically significant drug or alcohol abuse within the past 6 months
* Has prior exposure to tulisokibart
* Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Места на провеждане
15
Argentina (1)
CIPREC ( Site 0202)
CABA
Австралия (1)
Liverpool Hospital ( Site 1403)
Liverpool , New South Wales
Канада (1)
Wiseman Dermatology Research Inc. ( Site 0107)
Winnipeg , Manitoba
Chile (1)
Centro Skin Med Limitada ( Site 0305)
Santiago , Region M. de Santiago
Китай (1)
Dermatology Hospital of Southern Medical University ( Site 1504)
Guangzhou , Guangdong
Colombia (1)
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)
Medellín , Antioquia
Франция (1)
Hôpital Edouard Herriot ( Site 0601)
Lyon , Auvergne-Rhône-Alpes
Германия (1)
Frankfurt Universitaetsklinikum EC ( Site 0706)
Frankfurt am Main , Hesse
Италия (1)
AOU Ospedali Riuniti di Ancona ( Site 1805)
Ancona , The Marches
Япония (1)
Nagoya City University Hospital ( Site 1603)
Nagoya , Aichi-ken
Нидерландия (1)
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)
Breda , North Brabant
Сингапур (1)
National Universtity Hospital IMU ( Site 0802)
Singapore , Central Singapore
Испания (1)
Hospital de Manises ( Site 1103)
Manises , Valencia
Великобритания (1)
Russells Hall Hospital ( Site 1303)
Dudley , England
САЩ (1)
Cahaba Dermatology & Skin Health Center ( Site 0012)