Clinical trial NCT06567470: A Study With CIT-013 in RA Patients
Official title: A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Citryll BV
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period


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 ≥ 2 Swollen Joints, and ≥ 2 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
* At history of at least 3 months treatment and ≥ 4 weeks stable on a conventional synthetic disease modifying antirheumatic drug (csDMARD)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change in DAS28-CRP at week 12 compared to baseline
timeFrame: week 12
Secondary outcomes:
measure: Incidence of TEAEs as assessed by CTCAE
timeFrame: 12 weeks
measure: Maximum Plasma Concentration of CIT-013 before doses
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: München
country: Germany
facility: Schwerpunktpraxis für Rheumatologie und Gastroenterologie
city: Szeged
country: Hungary
facility: University of Szeged
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Białystok
country: Poland
facility: Centrum Zdrowia Stołeczna 7
city: Santander
country: Spain
facility: Marqués de Valdecilla University Hospital
Study officials:
affiliation: Citryll BV
name: Maarten Kraan
role: STUDY_DIRECTOR
References: