CIT-013 treatment for rheumatoid arthritis

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.

This trial will test whether CIT-013 can lower disease activity in adults with rheumatoid arthritis compared with a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Citryll BV (Industry-sponsored)
• Drugs / interventions: adalimumab, infliximab, certolizumab, golimumab, tocilizumab, sarilumab, rituximab
• Locations: 24 sites (Antwerp and 23 other locations)
• Trial ID: NCT06567470 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 trial assigns adults with active RA to low, medium, or high doses of CIT-013 or to placebo. Treatments are given every two weeks over a 12-week period with clinic visits and monitoring every two weeks for symptoms and safety tests. The trial's main outcome is change in disease activity (DAS28-CRP) and it will record adverse events to characterize safety. Results will compare CIT-013 dose groups to placebo to see if the drug reduces joint inflammation and other RA symptoms.

Who should consider this trial

Good fit: Adults 18–85 with rheumatoid arthritis by 2010 ACR/EULAR criteria who have active disease (DAS28-CRP ≥3.2 with ≥3 swollen and ≥3 tender joints) and are on a stable csDMARD are the ideal candidates.

Not a fit: Patients requiring immediate start of a biologic or JAK inhibitor, those with other active inflammatory joint diseases, or anyone with a contraindication to CIT-013 are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, CIT-013 could reduce joint inflammation and overall disease activity, improving symptoms and daily function for people with RA.

How similar studies have performed: CIT-013 is a relatively new therapy with limited prior efficacy data in RA, so this Phase 2 study builds on early safety work rather than an established record of success.

Eligibility criteria

Inclusion Criteria:

* Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
* Aged 18-85
* DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
* Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.

Exclusion Criteria:

* High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
* Contra-indication for CIT-013
* Current inflammatory joint disease other than RA (Sjogren with active disease is included).
* The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:

  1. ≥ 1 week for etanercept;
  2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
  3. ≥ 6 months year for rituximab;
  4. ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
* Treated with ≥ 3 bDMARD or tsDMARD
* Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.

Where this trial is running

Antwerp and 23 other locations

• Be-02 — Antwerp, Belgium (Not_yet_recruiting)
• Site BE-01 — Leuven, Belgium (Recruiting)
• De-04 — Bamberg, Germany (Recruiting)
• De-05 — Berlin, Germany (Recruiting)
• De-01 — München, Germany (Not_yet_recruiting)
• De-02 — München, Germany (Recruiting)
• De-03 — Ratingen, Germany (Recruiting)
• Nl-02 — Amsterdam, Netherlands (Recruiting)
• Nl-05 — Leeuwarden, Netherlands (Recruiting)
• Nl-04 — Leiden, Netherlands (Withdrawn)
• Nl-03 — Nijmegen, Netherlands (Not_yet_recruiting)
• Nl-01 — Rotterdam, Netherlands (Recruiting)
• Pl-01 — Bialystok, Poland (Recruiting)
• Pl-07 — Krakow, Poland (Recruiting)
• Pl-03 — Lublin, Poland (Recruiting)
• Pl-02 — Poznan, Poland (Recruiting)
• Pl-05 — Torun, Poland (Recruiting)
• Pl-04 — Warsaw, Poland (Recruiting)
• Es-02 — A Coruña, Spain (Recruiting)
• Es-04 — Barcelona, Spain (Recruiting)
• Es-05 — Barcelona, Spain (Not_yet_recruiting)
• Es-06 — Madrid, Spain (Recruiting)
• Es-01 — Santander, Spain (Not_yet_recruiting)
• Es-03 — Santiago de Compostela, Spain (Recruiting)

Study contacts

• Study coordinator: Leonie Middelink

Conditions Rheumatoid Arthritis