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Активно (без набиране) Фаза 2 NCT06257875

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Ulcerative Colitis

Спонсор: AbbVie

Налично на: БГ
Обобщение
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult participants with moderate to severe UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of moderate to severe UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 200 sites worldwide. During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab. Participants who do not respond to treatment will receive SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, 52-week long-term extension (LTE). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria: * Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available. * Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review). * Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies. Exclusion Criteria: * Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified. * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. * Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Participant may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
Места на провеждане 29
Австралия (1)
Bankstown-Lidcombe Hospital /ID# 259089
Bankstown , New South Wales
Белгия (1)
Universite Libre de Bruxelles - Hopital Erasme /ID# 258214
Anderlecht , Brussels Capital
България (1)
Hospital Tsaritsa Yoanna /ID# 258338
Sofiya , Sofia
Канада (1)
Gastroenterology and Internal Medicine Research Institution /ID# 258765
Edmonton , Alberta
Хърватия (1)
Klinicki bolnicki centar Zagreb /ID# 258145
Zagreb , City of Zagreb
Estonia (1)
West Tallinn Central Hospital /ID# 262035
Tallinn , Harju
Франция (1)
Chu de Nice-Hopital L'Archet Ii /Id# 258041
Nice , Alpes-Maritimes
Германия (1)
Universitaetsklinikum Ulm /ID# 258616
Ulm , Baden-Wurttemberg
Гърция (1)
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 257831
Athens , Attica
Унгария (1)
Clinfan /ID# 258094
Szekszárd , Tolna County
Ireland (1)
St Vincents University Hospital /ID# 261560
Elm Park , Dublin
Израел (1)
Yitzhak Shamir Medical Center /ID# 258533
Ẕerifin , Central District
Италия (1)
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 258455
Monserrato , Cagliari
Япония (1)
Gamagori City Hospital /ID# 260682
Gamagori-shi , Aichi-ken
Latvia (1)
SIA Polana-D /ID# 262932
Daugavpils
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 261486
Kaunas
New Zealand (1)
Dunedin Hospital /ID# 258584
Otago , Otago
Норвегия (1)
Akershus Universitetssykehus /ID# 261586
Nordbyhagen , Akershus
Полша (1)
Gastromed Sp. z o.o /ID# 258310
Torun , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
Clinical Research Investigator Group, LLC /ID# 260647
Bayamón
Сърбия (1)
Clinical Hosp Center Zvezdara /ID# 257766
Belgrade , Beograd
Словения (1)
General Hospital Celje /ID# 261482
Celje
South Africa (1)
Clinresco Centers /ID# 258431
Johannesburg , Gauteng
Южна Корея (1)
Inje University Haeundae Hospital /ID# 258822
Busan , Busan Gwang Yeogsi
Испания (1)
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 259114
Santiago de Compostela , A Coruna
Швейцария (1)
Inselspital, Universitaetsspital Bern /ID# 260106
Bern
Taiwan (1)
National Taiwan University Hospital /ID# 258476
Taipei City , Taipei
Великобритания (1)
Addenbrookes Hospital /ID# 258744
Cambridge , Cambridgeshire
САЩ (1)
Gastro SB /ID# 258331
Chula Vista , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.03.2024
Крайна дата
01.09.2027
Регистрационен номер
NCT06257875
Източник
anzctr
Запитване за медицински туризъм

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