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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 studied for the treatment of moderate to severe rheumatoid arthritis (RA). It is not yet approved for any indication. The clinical program has focused on evaluating its safety, tolerability, pharmacokinetics, and efficacy in adults with RA.
ABBV-3373 targets TNF and NR3C1. It is a small molecule binding agent designed to interact with both targets. TNF is a pro-inflammatory cytokine, and NR3C1 is the glucocorticoid receptor. This dual-target approach is being explored in immunology, specifically for rheumatoid arthritis.
ABBV-3373 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this asset.
ABBV-3373 is in Phase 2 clinical development. It has completed one Phase 2 trial in rheumatoid arthritis. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.
ABBV-3373 has been studied in one completed Phase 2 trial, NCT03823391, titled a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ABBV-3373 in participants with moderate to severe rheumatoid arthritis. The trial enrolled 48 participants across the United States, Germany, Hungary, Israel, Netherlands, Poland, and Puerto Rico.