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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02707562 | Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation) | PHASE2 | COMPLETED | 26 | — | — | Feb 1, 2016 | Nov 1, 2016 | Dec 7, 2016 | 16 | Australia, Czechia +3 |
| NCT02690519 | Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation) | PHASE2 | COMPLETED | 7 | — | — | Jan 1, 2016 | Sep 1, 2016 | Oct 11, 2016 | 5 | Belgium, Netherlands |
To evaluate the safety and tolerability of GLPG1837 in terms of adverse events at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs as measured by temperature, blood pressure, heart rate and respiratory rate, at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormalities during physical examination at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal electrocardiogram at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs at every visit
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal physical examination at every visit
| Arm | Type | Description |
|---|---|---|
| GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| GLPG1837 dose 1 and GLPG1837 dose 2 | EXPERIMENTAL | GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks |
| Name | Type | Description |
|---|---|---|
| GLPG1837 dose 1 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 2 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week |
| GLPG1837 dose 3 | DRUG | two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks |
Inclusion Criteria: * Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis * Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene * Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |