A Study With CIT-013 in RA Patients

• CIT-013 low dose (Drug): Subcutaneous injection
• CIT-013 high dose (Drug): Subcutaneous injection
• Placebo (Drug): Subcutaneous injection
• CIT-013 medium dose (Drug): CIT-013 medium dose

Primary outcomes

• The change in DAS28-CRP at week 6 compared to baseline [week 6]: Efficacy of CIT-013

Secondary outcomes

• Incidence of TEAEs as assessed by CTCAE [12 weeks]: Safety and tolerability of CIT-013
• Maximum Plasma Concentration of CIT-013 before doses [4, 6, 10 and 12 weeks]: CIT-013 levels

Sex: All, ages: 18 Years to any

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.

• Maarten Kraan, Study director, Citryll BV