Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNTO 6785 · 2 trials · 2 indications
FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
American College of Rheumatology (ACR) 20 response is a \>=20% improvement in rheumatoid arthritis (RA) symptoms.
| Arm | Type | Description |
|---|---|---|
| CNTO 6785 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Placebo/CNTO 6785 200 mg+Methotrexate (MTX) | PLACEBO_COMPARATOR | - |
| CNTO 6785 200 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 100 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 50 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 15 mg+MTX | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CNTO 6785 | DRUG | CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785. |
| Placebo | DRUG | Sterile, 5 percent dextrose will be used as the placebo in this study. Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12. |
| CNTO 6785 200 mg | DRUG | CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28 |
| CNTO 6785 100 mg | DRUG | CNTO 6785 100 mg SC every 4 weeks through Week 28 |
| CNTO 6785 50 mg | DRUG | CNTO 6785 50 mg SC every 4 weeks through Week 28 |
| CNTO 6785 15 mg | DRUG | CNTO 6785 15 mg SC every 4 weeks through Week 28 |
| Methotrexate (MTX) | DRUG | MTX at the same stable dose through Week 32, that participants were receiving prior to screening. |
Inclusion criteria: * Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) (Grade II or Grade III according to the GOLD Guidelines) with chronic bronchitis (sputum production on most days for at least 12 weeks per year for at least 2 successive years) at screening * Persistent COPD sympt...
CNTO 6785 is an investigational small molecule being studied for the treatment of rheumatoid arthritis and moderate to severe chronic obstructive pulmonary disease (COPD). It has also been evaluated in healthy volunteers to assess safety, tolerability, pharmacokinetics, and immunogenicity.
CNTO 6785 is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored clinical trials of the drug in healthy volunteers, rheumatoid arthritis, and chronic obstructive pulmonary disease.
CNTO 6785 has completed Phase 2 clinical trials for rheumatoid arthritis and chronic obstructive pulmonary disease. It also completed a Phase 1 study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
CNTO 6785 has been studied in three completed trials. NCT01288196 was a Phase 1 study in healthy volunteers. NCT01909427 was a Phase 2 trial in rheumatoid arthritis patients on methotrexate. NCT01966549 was a Phase 2 trial in moderate to severe COPD patients.
CNTO 6785 is a distinct investigational compound developed by Johnson & Johnson. No alternative names for this drug have been disclosed in clinical trial records.