A Study With CIT-013 in RA Patients

NCT06567470 | Recruiting Phase 2

• 1 other identifier: CITRYLL002
• Study Type: interventional
• Target: 88
• Locations: 5 countries
• Sites: 24

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 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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  Efficacy of CIT-013

  week 6

Secondary Outcomes (2)

• Incidence of TEAEs as assessed by CTCAE

  12 weeks

• Maximum Plasma Concentration of CIT-013 before doses

  4, 6, 10 and 12 weeks

Study Arms (4)

CIT-013 low dose

EXPERIMENTAL

3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013

Drug: CIT-013 low dose

CIT-013 high dose

EXPERIMENTAL

3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose

Drug: CIT-013 high dose

Placebo

PLACEBO COMPARATOR

3 SC injections with placebo and 3 SC injections with CIT-013 medium dose

Drug: Placebo

CIT-013 medium dose

EXPERIMENTAL

6 SC injections with CIT-013 medium dose

Drug: CIT-013 medium dose

Interventions

CIT-013 low dose DRUG

Subcutaneous injection

CIT-013 low dose

CIT-013 high dose DRUG

Subcutaneous injection

CIT-013 high dose

Placebo DRUG

Subcutaneous injection

Placebo

CIT-013 medium dose DRUG

CIT-013 medium dose

CIT-013 medium dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 week for etanercept;
• ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
• ≥ 6 months year for rituximab;
• ≥ 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.

Sponsors & Collaborators

• Citryll BV: lead

Study Sites (24)

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maarten Kraan

  Citryll BV

  STUDY DIRECTOR

Central Study Contacts

Leonie Middelink

CONTACT

0613328444; lmiddelink@citryll.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 22, 2024
• Study Start: July 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-11

Locations

BE (2); NL (5); PL (6); DE (5); ES (6)