2024-517081-42-00
Recruiting
Phase 2
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
Teva Branded Pharmaceutical Products R&D LLC5 sites in 1 country5 target enrollmentStarted: June 3, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Enrollment
- 5
- Locations
- 5
- Primary Endpoint
- Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.
Overview
Brief Summary
The primary efficacy objective of the trial is to assess the ability of a single dose of TEV-53408 administered sc to attenuate gluten-induced enteropathy in adults with celiac disease. The primary safety objective of the trial is to assess the safety of a single dose of TEV-53408 administered sc in adults with celiac disease up to week 28.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a. Male or female (assigned sex at birth) ≥18 to <65 years of age, inclusive, at the time of signing the informed consent.
- •j. Women of childbearing potential (WOCBP) must have a negative β-human chorionic gonadotropin (HCG) test result and practice a highly effective method of birth control prior to IMP administration and for the duration of trial participation, or for 5 half-lives of TEV-53408 (28 weeks) after IMP administration, whichever is longer.
- •k. Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period.
- •l. Male participants (including vasectomized) with WOCBP partners (whether pregnant or not) must use condoms and also agree not to donate sperm after IMP administration and for the duration of trial participation, or for 5 half-lives of TEV-53408 (28 weeks) after IMP administration, whichever is longer.
- •m. Participants should be capable of giving signed informed consent, and willing and able to comply with trial procedures, including duodenal biopsy both during screening and at week 8, maintaining the gluten challenge, and other restrictions.
- •b. Diagnosis of celiac disease at least 12 months prior to screening (documentation required at screening): − Participant has documentation of EGD confirming celiac disease and positive antibodies, or − If the participant is <30 years of age and a biopsy was not performed at the time of the celiac diagnosis, the participant had met the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) criteria for diagnosis.
- •c. On a gluten-free diet for at least 12 months prior to screening, as determined by the investigator through participant interview.
- •d. tTg IgA <2 U/mL at screening.
- •e. Minimal enteropathy as determined by Vh:Cd ≥2.0 on a duodenal biopsy (EGD) performed during screening period.
- •f. No moderate or severe gastrointestinal symptoms attributable to celiac disease at Screening (visit 1) based on the Symptom Screening Tool.
Exclusion Criteria
- •a. A diagnosis or suspicion of refractory celiac disease.
- •r. Participant has a known genetic or acquired immune deficiency.
- •s. Participant has a history of disseminated herpes simplex, multidermatomal, ophthalmic, recurrent herpes zoster, or herpes encephalitis.
- •b. History of severe celiac-related symptoms following gluten exposure that require acute medical care or intervention of a health care professional (either inpatient or outpatient) for management, dermatitis herpetiformis, or history of neurological symptoms including ataxia after gluten exposure.
- •t. Any participant that has a chronic or recurrent infection that the investigator believes does not fit any of the above exclusion criteria should be discussed with the medical monitor prior to enrollment in the trial.
- •u. Prior treatment with systemic immune suppressants or modulators including biological agents within the past 2 years for any condition (a brief course of 7 days or less of oral or parenteral corticosteroids for an emergent transient medical condition is allowed if use was >4 weeks prior to screening; up to 2 treatment courses per year).
- •v. Use of angiotensin II receptor blockers (eg, losartan, olmesartan, valsartan) within 4 weeks prior to screening.
- •w. Use of probiotic supplements within 4 weeks prior to randomization (probiotics in food [eg, yogurt] are allowed).
- •x. The participant has any of the following values from laboratory testing at screening (abnormal laboratory tests at the screening visit may be repeated once during the screening period): − aspartate aminotransferase (AST) >3 × upper limit of normal (ULN) − alanine aminotransferase (ALT) >3 × ULN − total bilirubin >1.5 × ULN (unless it is known to be secondary to Gilbert’s syndrome per the participant’s medical history) − creatine phosphokinase (CPK) >2.5 × ULN − lymphocyte count <1000 cells/μL − NK cell percentage below 4% of total lymphocytes. NK cell percentage is calculated as the ratio of CD56+ cells divided by the total lymphocyte count (CD45+ cells from T cell, B cell, and natural killer cell [TBNK] cell assay). If the total lymphocyte count is below the normal range, the denominator for the calculation will be the LLN for the lymphocyte count.
- •y. The participant has any other laboratory or physical examination findings or clinically significant electrocardiogram (ECG) result that might place the participant at an unacceptable risk for participation in this trial in the opinion of the investigator.
Arms & Interventions
TEV-53408
Test
Intervention: TEV-53408 (Drug)
Placebo to match TEV-53408
Placebo
Intervention: Placebo to match TEV-53408 (Drug)
Outcomes
Primary Outcomes
Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.
Incidence of early discontinuations during the treatment period (up to week 28) due to an adverse event.
Change from baseline in villous atrophy, as assessed by Vh:Cd, at week 8.
Change from baseline in villous atrophy, as assessed by Vh:Cd, at week 8.
Incidence of treatment-emergent adverse events up to week 28.
Incidence of treatment-emergent adverse events up to week 28.
Incidence of serious adverse events up to week 28.
Incidence of serious adverse events up to week 28.
Incidence of PDAESIs up to week 28.
Incidence of PDAESIs up to week 28.
Secondary Outcomes
- Change from baseline in IEL density at week 8.
- Change from baseline in a composite measure of VCIEL at week 8.
Investigators
Medical Information
Scientific
Teva Branded Pharmaceutical Products R&D LLC
Study Sites (5)
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