Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-292 · 4 trials · 3 indications
Percentage of participants with an American College of Rheumatology ≥20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from Baseline are met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein
Maximum observed concentration in plasma
Area under the plasma concentration-time curve from time zero to the last measured time point
Area under the plasma concentration-time curve to 24 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Percent Area under the plasma concentration-time curve extrapolated
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
Time to Cmax
Terminal disposition rate constant
Terminal half-life
Apparent clearance
Apparent volume of distribution
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| CC-292 375mg | EXPERIMENTAL | Treatment |
| Placebo | PLACEBO_COMPARATOR | Control |
| CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition | EXPERIMENTAL | Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) |
| CC-292 SDD 300mg - Fed Condition | EXPERIMENTAL | Single oral dose of 300 mg CC-292 SDD under fed conditions (100 mg SDD x 3 tablets) |
| 375mg P22 - Fasted condition | EXPERIMENTAL | Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) |
| 375mg P22 Fed Condition | EXPERIMENTAL | Single oral dose of 375 mg P22 under fed conditions (125 mg P22 x 3) |
| CC-292 SDD 100 mg Fasted Condition | EXPERIMENTAL | Single oral dose of 100 mg CC-292 SDD under fasted conditions |
| SDD plus OMP (Oral Omeprazole) | EXPERIMENTAL | Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg |
| P22 plus OMP | EXPERIMENTAL | Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP |
| CC-292 + Lenalidomide | EXPERIMENTAL | - |
| CC-292 with Rituximab | EXPERIMENTAL | Dose Escalation |
| Name | Type | Description |
|---|---|---|
| CC-292 | DRUG | 375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days) |
| Placebo | DRUG | Twice daily for 28 days |
| Oral Omeprazole (OMP) | DRUG | - |
| Lenalidomide | DRUG | Lenalidomde will be given once daily on Days 1-28 of 28-day cycles. |
| Rituximab | DRUG | Cohort 1: Rituximab once per cycle Cohort 2: Rituximab once per cycle |
Inclusion Criteria: * Female between 18 and 80 years of age (inclusive) at the time of signing the informed consent. * Must meet the 2010 ACR/EULAR Classification Criteria for RA (Appendix A), have RA for at least 6 months and must continue to have active RA at the time of randomization despite at ...
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CC-292 is an investigational small molecule being studied for rheumatoid arthritis, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma. It has also been evaluated in healthy volunteers for bioavailability studies. As of the available data, CC-292 is in clinical development and is not FDA approved.
CC-292 is a small molecule, but its specific molecular target is not disclosed in the available information. Therefore, its mechanism of action is not described here. It is being studied in autoimmune and hematologic conditions, but the exact biological target remains unspecified in the data provided.
CC-292 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various conditions, including rheumatoid arthritis and chronic lymphocytic leukemia.
CC-292 is in Phase 1 and Phase 2 clinical trials. The available data shows completed Phase 1 studies in chronic lymphocytic leukemia and healthy volunteers, as well as a completed Phase 2 study in rheumatoid arthritis. It remains investigational and is not approved by regulatory authorities.
CC-292 has been studied in several completed trials. NCT01732861 evaluated CC-292 with lenalidomide in CLL, NCT01744626 tested it with rituximab in CLL, NCT01975610 compared it to placebo with methotrexate in rheumatoid arthritis, and NCT02433457 assessed its bioavailability in healthy volunteers.
CC-292 is not known to have alternative names in the available data. It is referred to solely as CC-292 in the clinical trial records. No other names or aliases have been associated with this investigational drug in the information provided.