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ABBV-3373 · 1 trial · 1 indication
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
| Arm | Type | Description |
|---|---|---|
| ABBV-3373 Followed by Placebo | EXPERIMENTAL | Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22. |
| Adalimumab | EXPERIMENTAL | Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22. |
| Name | Type | Description |
|---|---|---|
| ABBV-3373 | DRUG | ABBV-3373 is administered as intravenous (IV) infusion |
| Placebo for ABBV-3373 | DRUG | Placebo for ABBV-3373 is administered as IV infusion |
| Adalimumab | DRUG | Adalimumab is administered as subcutaneous (SC) injection |
| Placebo for adalimumab | DRUG | Placebo for adalimumab is administered as subcutaneous (SC) injection |
Inclusion Criteria: * Participant has the clinical diagnosis of RA for \> 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria. * Participant meets the following disease activity criteria: \>= 4 swo...
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ABBV-3373 is an investigational small molecule being developed for the treatment of moderate to severe rheumatoid arthritis (RA). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
ABBV-3373 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in rheumatoid arthritis.
ABBV-3373 is in Phase 2 clinical development for rheumatoid arthritis. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness.
ABBV-3373 has been studied in a completed Phase 2 clinical trial identified as NCT03823391. This randomized, double-blind, controlled study enrolled 48 participants with moderate to severe rheumatoid arthritis and evaluated the drug's safety, tolerability, pharmacokinetics, and efficacy.
ABBV-3373 is a small molecule therapeutic, but its specific molecular target has not been disclosed. The drug is being investigated for its ability to treat rheumatoid arthritis, an autoimmune condition characterized by chronic joint inflammation.