CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
LAU-7b +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03265288
NCT03265288Phase 2Completed

APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults

Laurent Pharmaceuticals Inc.·interventional·Posted Aug 29, 2017·Updated Oct 9, 2024

In Brief

A Phase 2 clinical trial evaluating LAU-7b and Placebo oral capsule for Cystic Fibrosis. Completed, enrolled 166 participants across 40 sites in 3 countries.

Detailed Summary

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Canada, United States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 29, 2017
Enrollment StartNov 5, 2018
Primary CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.8 years ago

Interventions

LAU-7bdrug

LAU-7b will be administered orally once-a-day with the first meal of the day as cycles of 21 days on, 7 days off, for a total of 6 planned cycles.

Placebo oral capsuledrug

Placebo will be administered orally once-a-day with the first meal of the day as cycles of 21 days on, 7 days off, for a total of 6 planned cycles.