NCT03969888

A Phase 2 Study of an Active Drug Alone and in Combination With an Active Drug

Brief summary

This study will evaluate the safety, tolerability, and efficacy of an active drug given alone and in combination with various doses of an active drug in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

Interventional study

Status:
Recruiting
Conditions:
Cystic Fibrosis
Enrollment:
189 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-530
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the
F508del CF transmembrane conductance regulator (CFTR) mutation

- Stable pulmonary status

- Lung function >= 40 and <= 90% of predicted normal for age, gender and height at
Screening

Exclusion Criteria:

- History of solid organ or hematopoietic transplant

- Cirrhosis with portal hypertension

- Use of CFTR modulator therapy within 60 days prior to Screening

All the cities where the clinical studies are located

Calgary - T2N 4Z6

Edmonton - T6G 2G3

Vancouver - V6Z 1Y6

Halifax - B3H 4K4

Toronto - M5C 2T2

Montreal - H4A 3J1

Québec - G1V 4G5

British Columbia

Nova Scotia

Ontario