A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.

Official Summary

The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA. Participants will: Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 88 participants

Interventions

• DRUG: CIT-013 low dose — Subcutaneous injection
• DRUG: CIT-013 high dose — Subcutaneous injection
• DRUG: Placebo — Subcutaneous injection
• DRUG: CIT-013 medium dose — CIT-013 medium dose

Primary Outcomes

• The change in DAS28-CRP at week 6 compared to baseline (week 6)

Secondary Outcomes

• Incidence of TEAEs as assessed by CTCAE (12 weeks)
• Maximum Plasma Concentration of CIT-013 before doses (4, 6, 10 and 12 weeks)

Trial Locations

• BE-02, Antwerp, Belgium
• Site BE-01, Leuven, Belgium
• DE-04, Bamberg, Germany
• DE-05, Berlin, Germany
• DE-01, München, Germany
• DE-02, München, Germany
• DE-03, Ratingen, Germany
• NL-02, Amsterdam, Netherlands
• NL-05, Leeuwarden, Netherlands
• NL-04, Leiden, Netherlands
• ...and 10 more locations

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