Informations générales (source: ClinicalTrials.gov)
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis (ARTEMIS-UC)
Interventional
Phase 2
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (Voir sur ClinicalTrials)
juillet 2021
juin 2026
08 novembre 2024
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with moderately to severely active Ulcerative Colitis (UC). After the
completion of the 12-week induction, all participants have the option to continue in the
open-label extension for up to 170 weeks.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Prometheus Biosciences Selected Site - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Prometheus Biosciences Selected Site - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| Prometheus Biosciences Selected Site - 54511 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Prometheus Biosciences Selected Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Prometheus Biosciences Selected Site - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Prometheus Biosciences Selected Site - 92110 - Clichy - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Confirmed diagnosis of ulcerative colitis (UC)
- Has moderately to severely active UC as defined by 3-component Modified Mayo score
- Must have corticosteroid dependence or have had no response, insufficient response,
loss of response, and/or intolerance to at least one of the following therapies:
corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor
(anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK)
inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
The main inclusion criteria include but are not limited to the following:
- Confirmed diagnosis of ulcerative colitis (UC)
- Has moderately to severely active UC as defined by 3-component Modified Mayo score
- Must have corticosteroid dependence or have had no response, insufficient response,
loss of response, and/or intolerance to at least one of the following therapies:
corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor
(anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK)
inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
The main exclusion criteria include but are not limited to the following:
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total
proctocoloectomy or partial colectomy
- Has current or impending need for colostomy or ileostomy
- Has had surgical bowel resection within 3 months before screening
- Has past or current evidence of definite low-grade or high-grade colonic dysplasia
not completely removed