A Study With CIT-013 in RA Patients

Sponsor
Citryll BV
Study ID
NCT06567470
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

First listed
Aug 22, 2024
Start date
Jul 29, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CIT-013 low dose
    3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013
  • Experimental: CIT-013 high dose
    3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose
  • Placebo Comparator: Placebo
    3 SC injections with placebo and 3 SC injections with CIT-013 medium dose
  • Experimental: CIT-013 medium dose
    6 SC injections with CIT-013 medium dose

Primary Outcome Measure

The change in DAS28-CRP at week 6 compared to baseline [ Time Frame: week 6 ]

Central Contacts

Find similar trials

Nationwide
Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

Related Studies