drugset / Trial / NCT05497284
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Timeline
- Start
- 2022-11-10
- Primary completion
- 2024-08-26
- Completion
- 2024-09-26
Outcome
Missed primary endpoint
Stopped (Business): “Sponsor Decision”
registry Slope -2.6 (80% CI -6.9 to 1.3); Baysesian random slope model; note: Probability that LTP001 is better than placebo is 10.3% NCT05497284 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LTP001 | Unknown | — | Oral |
| Background | Nintedanib | Small molecule | — | — |
| Background | Pirfenidone | Small molecule | — | — |