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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03969888 | A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 | PHASE2 | COMPLETED | 78 | — | — | Dec 11, 2019 | Jun 9, 2022 | Jun 28, 2023 | 51 | United States, Belgium +10 |
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
| Arm | Type | Description |
|---|---|---|
| ABBV-3067 50 mg + Placebo for ABBV-2222 | EXPERIMENTAL | Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days. |
| ABBV-3067 150 mg + Placebo for ABBV-2222 | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days. |
| ABBV-3067 150 mg + ABBV-2222 10 mg | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days. |
| ABBV-3067 150 mg + ABBV-2222 30 mg | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days. |
| ABBV-3067 150 mg + ABBV-2222 100 mg | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days. |
| ABBV-3067 150 mg + ABBV-2222 200 mg | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days. |
| ABBV-3067 150 mg + ABBV-2222 300 mg | EXPERIMENTAL | Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days. |
| Placebo for ABBV-3067 + Placebo for ABBV-2222 | PLACEBO_COMPARATOR | Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-3067 | DRUG | Tablet taken orally. |
| Placebo ABBV-3067 | DRUG | Tablet taken orally. |
| ABBV-2222 | DRUG | Capsule taken orally. |
| Placebo ABBV-2222 | DRUG | Capsule taken orally. |
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 Cr...
| 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 |