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Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults

NCT03265288 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-10-09

Study results available
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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.

Conditions

Interventions

DRUG

LAU-7b

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.

DRUG

Placebo oral capsule

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.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Laurent Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Larry C Lands, MD PhD · McGill Uinversity Health Centre

  • Michael W Konstan, MD · Rainbow Babies and Children's Hospital/ University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2021-09-15
Completion
2021-09-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265288 on ClinicalTrials.gov