Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-292 · 3 trials · 2 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
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| CC-292 375mg | EXPERIMENTAL | Treatment |
| Placebo | PLACEBO_COMPARATOR | Control |
| 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 |
| 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 has been studied in chronic lymphocytic leukemia and small lymphocytic lymphoma, as well as in rheumatoid arthritis. Bristol-Myers Squibb developed it as an oral small molecule. The rheumatoid arthritis study evaluated CC-292 as co-therapy with methotrexate, while the leukemia studies combined it with rituximab or lenalidomide.
CC-292 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical trials of CC-292 in chronic lymphocytic leukemia, small lymphocytic lymphoma, and rheumatoid arthritis.
CC-292 is an investigational drug that has been tested in Phase 1 and Phase 2 clinical trials. It has not been approved by the FDA. The Phase 1 studies evaluated CC-292 in chronic lymphocytic leukemia and small lymphocytic lymphoma, and a Phase 2 study evaluated it in rheumatoid arthritis.
CC-292 has been studied in three completed clinical trials. NCT01744626 was a Phase 1 safety study of CC-292 with rituximab in chronic lymphocytic leukemia and small lymphocytic lymphoma. NCT01732861 was a Phase 1 safety study of CC-292 with lenalidomide in the same conditions. NCT01975610 was a Phase 2 study of CC-292 with methotrexate in rheumatoid arthritis.
The CC-292 clinical trials enrolled a total of 107 participants across three completed studies. The Phase 1 study with rituximab enrolled 40 subjects, the Phase 1 study with lenalidomide enrolled 20 subjects, and the Phase 2 rheumatoid arthritis study enrolled 47 subjects.