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Clinical trial

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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Last updated:22nd Dec 2017
Identifier: NCT03451045

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, Europe, and Australia. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Actual Study Start Date: December 22, 2017
Estimated Primary Completion Date: September 2019
Estimated Study Completion Date: November 2019

- Experimental:
Lenabasum 20 mg BID
- Experimental: Lenabasum 5 mg BID
- Placebo Comparator: Placebo BID

Category Value
Date last updated at source 2019-07-03
Study type(s) Interventional
Expected enrolment 415
Study start date 2017-12-22
Estimated primary completion date 2019-09-01

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