Trial abstract · §2
CELIAC-PH2B — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Arms
- 3
- Allocation
- Randomised across dose arms and a common comparator
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Larazotide acetate, dose level 1 | 116 | 33.9 % | Randomised dose arm |
| Larazotide acetate, dose level 2 | 123 | 36.0 % | Randomised dose arm |
| Placebo | 103 | 30.1 % | Matched placebo |
| Randomised total 342 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indication. Inflammatory bowel disease and mucosal barrier disorders
Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
Geographic footprint. Canada · Netherlands · Japan · Republic of Korea · Taiwan · Argentina.
§2.4Eligibility as the Institute reads it
- Included. Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
- Excluded. Participants for whom the intervention is contraindicated, including not established — no marketing authorisation. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0129/2 · https://compoundevidence.com/trials/celiac-ph2b/design/ · retrieved 30 July 2026