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Restore CFTR Protein Closed to Enrollment
SNO7: Phase 2 study of N91115 in adults with CF who are currently taking ivacaftor (Nivalis N91115-2CF-06)
This study will look at the safety and effectiveness of the oral drug N91115 when taken along with ivacaftor (Kalydeco). This study is placebo-controlled, meaning that study participants will receive either N91115 or a placebo. Researchers will test the effectiveness of N91115 by measuring lung function. They will also measure its safety by tracking adverse events. This study is for people with CF who are currently taking ivacaftor (Kalydeco). This study may require lung function tests, sweat chloride tests, blood draws and/or other measurements.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Patients must be heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R) and are receiving treatment with ivacaftor in accordance with its prescribing information.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
12 weeks -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Nivalis -
Study Drugs:
Study Sites
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Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
-
Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21287
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Boston, MA 02115
-
Closed to Enrollment
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
-
Closed to Enrollment
New York
Children's Hospital of New York, New York, NY 10032
-
Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
-
Closed to Enrollment
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
-
Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
-
Closed to Enrollment
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
-
Closed to Enrollment
Utah
Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113
-
Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Patients must be heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R) and are receiving treatment with ivacaftor in accordance with its prescribing information.

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