Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03119649 | A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis | PHASE2 | COMPLETED | 59 | — | — | Mar 18, 2017 | Oct 19, 2017 | Nov 16, 2018 | 23 | United States, Belgium +4 |
| NCT03540524 | A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis. | PHASE1 | COMPLETED | 10 | — | — | May 31, 2018 | Mar 11, 2019 | Apr 8, 2019 | 20 | Belgium, Bulgaria +6 |
Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
To assess safety and tolerability of doses of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To characterize the pharmacokinetics (PK) of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
| Arm | Type | Description |
|---|---|---|
| Cohort A: GLPG2222 50 mg once daily (QD) | EXPERIMENTAL | Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets orally, QD for 29 days. |
| Cohort A: GLPG2222 100 mg QD | EXPERIMENTAL | Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets orally, QD for 29 days. |
| Cohort B: GLPG2222 200 mg QD | EXPERIMENTAL | Participants received two GLPG2222 100 mg tablets and one matching placebo tablet orally, QD for 29 days. |
| Cohort B: GLPG2222 400 mg QD | EXPERIMENTAL | Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days. |
| Cohort A Placebo | PLACEBO_COMPARATOR | Participants received three matching placebo tablets, orally, QD for 29 days. |
| Cohort B Placebo | PLACEBO_COMPARATOR | Participants received three matching placebo tablets, orally, QD for 29 days. |
| Cohort A - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods.( Study Part I) |
| Cohort B - F508del heterozygous/potentiator nonresponsive | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (study Part II) |
| Cohort C - F508del homozygous | EXPERIMENTAL | Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (Study Part II) |
| Name | Type | Description |
|---|---|---|
| GLPG2222 50 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2222 100 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| Placebo | DRUG | Matching oral tablet(s) containing placebo |
| GLPG2222 200 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2222 400 mg | DRUG | Oral tablet(s) containing GLPG2222 |
| GLPG2451 dose regimen A | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2451 dose regimen B | DRUG | GLPG2451 oral suspension, daily. |
| GLPG2222 | DRUG | GLPG2222 tablet for oral use, daily. |
| GLPG2737 | DRUG | GLPG2737 capsules for oral use, daily. |
Inclusion Criteria: 1. Male or female subject ≥ 18 years of age, on the day of signing the Informed Consent Form (ICF). 2. A confirmed clinical diagnosis of CF and homozygous for the F508del CFTR mutation 3. Weight ≥ 40 kg. 4. Stable concomitant treatment for at least 4 weeks (28 days) prior to bas...
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|---|---|---|---|---|
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