Trial abstract
STEPS-2 — structured trial abstract
STEPS-2 — Teduglutide in mucosal barrier: single-arm open-label
§1Structured abstract
§1.1Objective
To evaluate Teduglutide in inflammatory bowel disease and mucosal barrier disorders, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Single-arm open-label study
- Masking
- None
- Phase
- Phase 3
- Randomised participants
- 88
- Duration of the primary analysis period
- 24 months
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Sustained reduction in parenteral support volume during open-label extension
§1.4Principal result
Reductions were maintained during extended open-label treatment; the Institute records extension data as descriptive rather than comparative.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
Compound Evidence Institute · CEI-TR-0140 · https://compoundevidence.com/trials/steps-2/ · retrieved 30 July 2026