A Study With CIT-013 in RA Patients

Phase 2

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: CIT-013 low dose; Drug: CIT-013 high dose; Drug: Placebo

• Registration Number: NCT06567470
• Lead Sponsor: Citryll BV

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Study Start: 2024-11
• Primary Completion: 2027-04
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIT-013 low dose	CIT-013 low dose	6 SC injections with low dose CIT-013
CIT-013 high dose	CIT-013 high dose	6 SC injections with CIT-013
Placebo	Placebo	6 SC injections with placebo

Primary Outcome Measures

Name	Time	Method
The change in DAS28-CRP at week 12 compared to baseline	week 12	Efficacy of CIT-013

Secondary Outcome Measures

Name	Time	Method
Incidence of TEAEs as assessed by CTCAE	12 weeks	Safety and tolerability of CIT-013
Maximum Plasma Concentration of CIT-013 before doses	4, 8 and 12 weeks	CIT-013 levels

Trial Locations

Locations (7)

Schwerpunktpraxis für Rheumatologie und Gastroenterologie; 🇩🇪 München, Germany

University of Szeged; 🇭🇺 Szeged, Hungary

Centrum Zdrowia Stołeczna 7; 🇵🇱 Białystok, Poland

Radboud UMC; 🇳🇱 Nijmegen, Netherlands

Marqués de Valdecilla University Hospital; 🇪🇸 Santander, Spain

UZ Leuven; 🇧🇪 Leuven, Belgium

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands