Trial results for nipocalimab in participants with active rheumatoid arthritis were posted on ClinicalTrials.gov on 2025-08-22. The Phase 2 study showed that 45.5% of participants receiving nipocalimab achieved an ACR20 response at Week 12, compared to 20.0% for those on placebo.
Background
The study aimed to evaluate the efficacy and safety of nipocalimab in participants with moderate to severe active rheumatoid arthritis (RA).
Trial design
The proof-of-concept study (NCT04991753) was a Phase 2, randomized, placebo-controlled trial. It enrolled 53 participants with moderate to severe active rheumatoid arthritis. The study investigated nipocalimab versus placebo to evaluate its efficacy and safety.
Key results
Key measurements from the trial at Week 12 included:
- Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP): The least squares mean change was -0.58 for the placebo group and -1.03 for the nipocalimab group. An ANCOVA analysis showed a least square mean difference of -0.45 (95.0% Confidence Interval: -1.17 to 0.28) between nipocalimab and placebo, with a p-value of 0.224.
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20: 45.5% of participants in the nipocalimab group achieved ACR20, compared to 20.0% in the placebo group.
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50: 15.2% of participants in the nipocalimab group achieved ACR50, compared to 5.0% in the placebo group.
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70: 12.1% of participants in the nipocalimab group achieved ACR70, compared to 0% in the placebo group.
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90: 6.1% of participants in the nipocalimab group achieved ACR90, compared to 0% in the placebo group.
- Percentage of Participants Who Achieved DAS28-CRP Remission: 21.2% of participants in the nipocalimab group achieved remission, compared to 10.0% in the placebo group.
What this means
The Phase 2 trial results for nipocalimab in rheumatoid arthritis show numerical differences favoring the investigational drug over placebo across several key efficacy measures. While the change from baseline in DAS28-CRP did not reach statistical significance (p=0.224), the higher percentages of participants achieving ACR20, ACR50, ACR70, ACR90, and DAS28-CRP remission in the nipocalimab group suggest potential clinical activity. These findings warrant further investigation in larger clinical trials to determine the full therapeutic potential of nipocalimab for patients with rheumatoid arthritis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04991753, titled "A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis," were posted on 2025-08-22 on clinicaltrials.gov.