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Report for Clinical Trial NCT02971839

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations.

This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.

NCT02971839 Cystic Fibrosis
MeSH: Cystic Fibrosis Fibrosis

5 Interventions

Name: CTP-656, 20 mg (QD)

Type: Drug

CTP-656, 20 mg, QD

Name: CTP-656, 100 mg (QD)

Type: Drug

CTP-656, 100 mg, QD

Name: CTP-656, 150 mg (QD)

Type: Drug

CTP-656, 150 mg, QD

Name: Placebo (QD)

Type: Drug

Placebo, Oral Tablet, QD

Name: Kalydeco, 150 mg Tablet (BID; open-label)

Type: Drug

Kalydeco, 150 mg Tablet (open label)


Primary Outcomes

Measure: Change from baseline in sweat chloride at Day 28

Time: 28 days

Secondary Outcomes

Measure: Change from baseline in percent predicted FEV1 at Day 28

Time: 28 days

Measure: Change from baseline in CFQ-R Respiratory Domain at Day 28

Time: 28 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 9 SNPs

SNPs


1 G1244E

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E ---


2 G1349D

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D ---


3 G178R

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R ---


4 G551D

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D ---


5 G551S

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S ---


6 S1251N

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N ---


7 S1255P

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P ---


8 S549N

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N ---


9 S549R

Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R ---

Exclusion Criteria: - Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment - Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes - History of hepatitis C or chronic active hepatitis B infection - History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening - Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening - Abnormal liver function - History of abnormal renal function - History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females - History of solid organ or hematological transplantation - Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening - Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose Inclusion Criteria: - 18 years of age or older - Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R ---



HPO Nodes