A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
A legfontosabb adatok
- Hol
- Atlanta, Clinton Township, Colorado Springs, Greenville, Inverness, Lynchburg, Marrero, Miami Lakes, Murrieta, New Port Richey, New York, Ogden, Rochester, Waco, Winston-Salem és Wyoming (Egyesült Államok)Mind a 16 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Clinton Township, MichiganHospital not named in the registryNo longer taking part
- Colorado Springs, ColoradoHospital not named in the registryNo longer taking part
- Greenville, North CarolinaHospital not named in the registryNo longer taking part
- Inverness, FloridaHospital not named in the registryNo longer taking part
- Lynchburg, VirginiaHospital not named in the registryNo longer taking part
- Marrero, LouisianaHospital not named in the registryNo longer taking part
- Miami Lakes, FloridaHospital not named in the registryNo longer taking part
- Murrieta, CaliforniaHospital not named in the registryNo longer taking part
- New Port Richey, FloridaHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Ogden, UtahHospital not named in the registryNo longer taking part
- Rochester, MinnesotaHospital not named in the registryNo longer taking part
- Waco, TexasHospital not named in the registryNo longer taking part
- Winston-Salem, North CarolinaHospital not named in the registryNo longer taking part
- Wyoming, MichiganHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- Teva Branded Pharmaceutical Products R&D LLC
- Azonosító
- NCT06807463EU 2024-517081-42-00
- A regiszteradat frissítve
- 2026. október 9.
- Eredeti leírás
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.A teljes eredeti leírásKevesebb
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Trial to Characterize the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease While Undergoing Oral Gluten Exposure
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.
The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.
A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.
The expected trial duration per participant is approximately 86 weeks.
Bevonási feltételek: Diagnosis of celiac disease at least 12 months prior to screening; On a gluten-free diet for at least 12 months prior to screening; Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period; Male participants (including vasectomized) with women of child-bearing potential partners (whether pregnant or not) must use condoms and also agree not to donate sperm for the designated period; NOTE - Additional criteria apply, please contact the investigator for more information.
Kizáró feltételek: A history of chronic alcohol or substance abuse disorder within the previous 2 years; An active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening; Received or intends to receive any live vaccine within 4 weeks or any non-live vaccine 2 weeks prior to investigational medicinal product administration; NOTE- Additional criteria apply, please contact the investigator for more information; A diagnosis or suspicion of refractory celiac disease; History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional; Any other gastrointestinal disease or condition that may interfere with the assessment of celiac disease; Current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma; Pregnant or lactating woman, or plans to become pregnant during the trial; any man who is considering fathering a child or donating sperm during the trial.