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Активно (без набиране) Фаза 3 NCT04901195

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Фаза 3 – широко изпитване преди одобрение
Заболявания: Hidradenitis Suppurativa

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
Кой може да участва
Inclusion Criteria: * Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study * Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator * A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP) Exclusion Criteria: * Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP) * Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator. * Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated * Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment * Study participant plans to participate in another study of a medicinal product or device under investigation during this study
Интервенции
Bimekizumab
DRUG
Места на провеждане 145
Австралия (8)
Hs0005 30015
Campbelltown
Hs0005 30016
Carlton
Hs0005 30011
East Melbourne
Hs0005 30017
Kogarah
Hs0005 30018
Parkville
Hs0005 30014
St Leonards
Hs0005 30009
Westmead
Hs0005 30012
Woolloongabba
Белгия (2)
Hs0005 40002
Leuven
Hs0005 40121
Woluwe-Saint-Lambert
България (6)
Hs0005 40313
Pleven
Hs0005 40284
Sofia
Hs0005 40311
Sofia
Hs0005 40314
Sofia
Hs0005 40315
Sofia
Hs0005 40353
Stara Zagora
Канада (9)
Hs0005 50233
Barrie
Hs0005 50172
Cobourg
Hs0005 50135
Edmonton
Hs0005 50174
London
Hs0005 50190
Richmond Hill
Hs0005 50192
Saskatoon
Hs0005 50133
Surrey
Hs0005 50134
Waterloo
Hs0005 50136
Winnipeg
Чехия (2)
Hs0005 40194
Prague
Hs0005 40063
Prague
Франция (14)
Hs0005 40197
Amiens
Hs0005 40245
Antony
Hs0005 40321
Auxerre
Hs0005 40320
La Rochelle
Hs0005 40355
Le Mans
Hs0005 40247
Lyon
Hs0005 40130
Marseille
Hs0005 40132
Nice
Hs0005 40404
Reims
Hs0005 40318
Rouen
Hs0005 40403
Saint-Etienne
Hs0005 40246
Saint-Mandé
Hs0005 40285
Toulon
Hs0005 40286
Toulouse
Германия (15)
Hs0005 40325
Berlin
Hs0005 40326
Berlin
Hs0005 40248
Bochum
Hs0005 40327
Bonn
Hs0005 40288
Darmstadt
Hs0005 40324
Dresden
Hs0005 40356
Dresden
Hs0005 40287
Frankfurt am Main
Hs0005 40142
Hamburg
Hs0005 40328
Hanover
Hs0005 40249
Kiel
Hs0005 40250
Lübeck
Hs0005 40174
Mainz
Hs0005 40323
München
Hs0005 40177
Münster
Гърция (2)
Hs0005 40251
Athens
Hs0005 40252
Efkarpia
Унгария (1)
Hs0005 40254
Debrecen
Ireland (1)
Hs0005 40344
Dublin
Италия (4)
Hs0005 40261
Catania
Hs0005 40263
Roma
Hs0005 40258
Rozzano
Hs0005 40330
Torino
Япония (13)
Hs0005 20196
Bunkyō City
Hs0005 20144
Fukuoka
Hs0005 20043
Itabashi-ku
Hs0005 20195
Kagoshima
Hs0005 20170
Kurume
Hs0005 20190
Kyoto
Hs0005 20033
Nagoya
Hs0005 20152
Nakagami-gun
Hs0005 20178
Nishinomiya
Hs0005 20153
Obihiro
Hs0005 20037
Osaka
Hs0005 20154
Sapporo
Hs0005 20171
Sendai
Нидерландия (3)
Hs0005 40351
Breda
Hs0005 40292
Groningen
Hs0005 40264
Rotterdam
Полша (6)
Hs0005 40347
Lodz
Hs0005 40293
Rzeszów
Hs0005 40335
Warsaw
Hs0005 40095
Wroclaw
Hs0005 40333
Wroclaw
Hs0005 40334
Wroclaw
Испания (10)
Hs0005 40266
Badalona
Hs0005 40159
Barcelona
Hs0005 40267
Barcelona
Hs0005 40298
Granada
Hs0005 40294
Las Palmas de Gran Canaria
Hs0005 40268
Madrid
Hs0005 40297
Manises
Hs0005 40295
Pontevedra
Hs0005 40049
Seville
Hs0005 40230
Valencia
Швейцария (1)
Hs0005 40406
Geneva
Турция (4)
Hs0005 40270
Antalya
Hs0005 40273
Gaziantep
Hs0005 40272
Istanbul
Hs0005 40271
Izmir
Великобритания (1)
Hs0005 40339
Leeds
САЩ (43)
Hs0005 50237
Albuquerque , New Mexico
Hs0005 50201
Arlington , Texas
Hs0005 50198
Beverly , Massachusetts
Hs0005 50140
Birmingham , Alabama
Hs0005 50146
Boston , Massachusetts
Hs0005 50151
Chapel Hill , North Carolina
Hs0005 50084
Charleston , South Carolina
Hs0005 50177
Cincinnati , Ohio
Hs0005 50178
Clarkston , Michigan
Hs0005 50138
Columbus , Ohio
Hs0005 50145
Columbus , Ohio
Hs0005 50211
Durham , North Carolina
Hs0005 50137
East Windsor , New Jersey
Hs0005 50202
Fairborn , Ohio
Hs0005 50162
Fountain Valley , California
Hs0005 50236
Greenville , South Carolina
Hs0005 50147
Hershey , Pennsylvania
Hs0005 50008
Johnston , Rhode Island
Hs0005 50208
Las Vegas , Nevada
Hs0005 50161
Los Angeles , California
Hs0005 50199
Miami , Florida
Hs0005 50425
Murray , Kentucky
Hs0005 50142
Nashville , Tennessee
Hs0005 50235
New York , New York
Hs0005 50159
Newington , New Hampshire
Hs0005 50205
North Miami Beach , Florida
Hs0005 50194
Omaha , Nebraska
Hs0005 50152
Orange Park , Florida
Hs0005 50184
Pembroke Pines , Florida
Hs0005 50148
Pflugerville , Texas
Hs0005 50175
Phoenix , Arizona
Hs0005 50234
Plainfield , Indiana
Hs0005 50180
Providence , Rhode Island
Hs0005 50141
Salt Lake City , Utah
Hs0005 50220
San Diego , California
Hs0005 50193
Sandy Springs , Georgia
Hs0005 50270
Seattle , Washington
Hs0005 50105
St Louis , Missouri
Hs0005 50196
Thousand Oaks , California
Hs0005 50204
Tulsa , Oklahoma
Hs0005 50200
Verona , New Jersey
Hs0005 50280
Watkinsville , Georgia
Hs0005 50179
Winston-Salem , North Carolina
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
27.05.2021
Крайна дата
28.07.2026
Регистрационен номер
NCT04901195
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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