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Also known as Navocaftor
ABBV-3067 · 1 trial · 1 indication
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...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
ABBV-3067 is an investigational small molecule being studied for the treatment of cystic fibrosis, a genetic disorder affecting the lungs and other organs. It is being developed by AbbVie Inc. and has completed a Phase 2 clinical trial in adults with cystic fibrosis.
ABBV-3067 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is responsible for the clinical development of the drug.
ABBV-3067 is in Phase 2 clinical development. A Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
ABBV-3067 has been evaluated in a completed Phase 2 trial, NCT03969888, titled "A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222." The trial enrolled 78 participants with cystic fibrosis across multiple countries, including the United States, Belgium, Canada, and others.
Yes, the Phase 2 trial of ABBV-3067 (NCT03969888) was randomized, double-blind, and placebo-controlled. It enrolled 78 adults with cystic fibrosis and was completed. The study also included a biomarker-selected population.