Indication assessment · §3
Inflammatory bowel disease and mucosal barrier disorders — trial records
Trial records in the Institute's register bearing on inflammatory bowel disease and mucosal barrier disorders.
§3Trials in this indication
27 trial records in the Institute's register bear on this indication, of which 6 are published trials.
Table 2. Trial records bearing on inflammatory bowel disease and mucosal barrier disorders.
| Record | Compound | Phase | Design | Randomised | Year |
|---|---|---|---|---|---|
| BPC-PH2-UC | BPC-157 | Phase 2 | Randomised, double-blind, placebo-controlled | — | — |
| CELIAC-PH2B | Larazotide acetate | Phase 2b | Randomised, double-blind, placebo-controlled | 342 | 2015 |
| CELIAC-PH3-CEDLARA | Larazotide acetate | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2022 |
| STEPS | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | 86 | 2012 |
| STEPS-2 | Teduglutide | Phase 3 | Single-arm open-label | 88 | 2013 |
| TED-PAEDIATRIC | Teduglutide | Phase 3 | Single-arm open-label | 59 | 2020 |
| BPC-PH2-UC-REGIONAL-JPprogramme record | BPC-157 | Phase 3 | Randomised, double-blind, placebo-controlled | — | — |
| CELIAC-PH2B-PKprogramme record | Larazotide acetate | Phase 1 | Phase 1 ascending dose | — | 2015 |
| CELIAC-PH3-CEDLARA-BODY-COMPprogramme record | Larazotide acetate | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2022 |
| STEPS-DDIprogramme record | Teduglutide | Phase 1 | Randomised crossover | — | 2012 |
| STEPS-2-ELDERLYprogramme record | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2013 |
| TED-PAEDIATRIC-REGIONAL-CNprogramme record | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2020 |
| BPC-PH2-UC-BODY-COMPprogramme record | BPC-157 | Phase 2 | Randomised, double-blind, placebo-controlled | — | — |
| CELIAC-PH2B-RENAL-IMPprogramme record | Larazotide acetate | Phase 1 | Phase 1 ascending dose | — | 2015 |
| CELIAC-PH3-CEDLARA-REGIONAL-JPprogramme record | Larazotide acetate | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2022 |
| STEPS-HEPATIC-IMPprogramme record | Teduglutide | Phase 1 | Phase 1 ascending dose | — | 2012 |
| STEPS-2-OLEprogramme record | Teduglutide | Phase 3 | Single-arm open-label | — | 2013 |
| BPC-PH2-UC-QOLprogramme record | BPC-157 | Phase 2 | Randomised, double-blind, placebo-controlled | — | — |
| CELIAC-PH2B-HEPATIC-IMPprogramme record | Larazotide acetate | Phase 1 | Phase 1 ascending dose | — | 2015 |
| STEPS-RENAL-IMPprogramme record | Teduglutide | Phase 1 | Phase 1 ascending dose | — | 2012 |
| STEPS-2-ADHERENCEprogramme record | Teduglutide | Phase 3 | Observational | — | 2013 |
| TED-PAEDIATRIC-BODY-COMPprogramme record | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2020 |
| BPC-PH2-UC-REGIONAL-CNprogramme record | BPC-157 | Phase 3 | Randomised, double-blind, placebo-controlled | — | — |
| CELIAC-PH2B-DDIprogramme record | Larazotide acetate | Phase 1 | Randomised crossover | — | 2015 |
| STEPS-PKprogramme record | Teduglutide | Phase 1 | Phase 1 ascending dose | — | 2012 |
| STEPS-2-BIOMARKERprogramme record | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2013 |
| TED-PAEDIATRIC-REGIONAL-JPprogramme record | Teduglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2020 |
| This facet in the trial register. | |||||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-IN-24/3 · https://compoundevidence.com/indications/ibd/trials/ · retrieved 30 July 2026