Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
88 participants
INTERVENTIONAL
2025-07-29
2027-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CIT-013 low dose
3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013
CIT-013 low dose
Subcutaneous injection
CIT-013 high dose
3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose
CIT-013 high dose
Subcutaneous injection
Placebo
3 SC injections with placebo and 3 SC injections with CIT-013 medium dose
Placebo
Subcutaneous injection
CIT-013 medium dose
6 SC injections with CIT-013 medium dose
CIT-013 medium dose
CIT-013 medium dose
Interventions
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CIT-013 low dose
Subcutaneous injection
CIT-013 high dose
Subcutaneous injection
Placebo
Subcutaneous injection
CIT-013 medium dose
CIT-013 medium dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Citryll BV
INDUSTRY
Responsible Party
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Principal Investigators
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Maarten Kraan
Role: STUDY_DIRECTOR
Citryll BV
Locations
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BE-02
Antwerp, , Belgium
Site BE-01
Leuven, , Belgium
DE-04
Bamberg, , Germany
DE-05
Berlin, , Germany
DE-01
München, , Germany
DE-02
München, , Germany
DE-03
Ratingen, , Germany
NL-02
Amsterdam, , Netherlands
NL-05
Leeuwarden, , Netherlands
NL-04
Leiden, , Netherlands
NL-03
Nijmegen, , Netherlands
NL-01
Rotterdam, , Netherlands
PL-01
Bialystok, , Poland
PL-03
Lublin, , Poland
PL-02
Poznan, , Poland
PL-05
Torun, , Poland
PL-04
Warsaw, , Poland
ES-02
A Coruña, , Spain
ES-04
Barcelona, , Spain
ES-05
Barcelona, , Spain
ES-06
Madrid, , Spain
ES-01
Santander, , Spain
ES-03
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Facility Contacts
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PI BE-02
Role: primary
PI BE-01
Role: primary
PI DE-04
Role: primary
PI DE-05
Role: primary
PI DE-01
Role: primary
PI DE-02
Role: primary
PI DE-03
Role: primary
PI NL-02
Role: primary
PI NL-05
Role: primary
PI NL04
Role: primary
PI NL-03
Role: primary
PI NL-01
Role: primary
PI PL-01
Role: primary
PI PL-03
Role: primary
PI PL-02
Role: primary
PI PL-05
Role: primary
PI PL-04
Role: primary
PI ES-02
Role: primary
PI ES-04
Role: primary
PI ES-05
Role: primary
PI ES-06
Role: primary
PI ES-01
Role: primary
PI ES-03
Role: primary
Other Identifiers
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CITRYLL002
Identifier Type: -
Identifier Source: org_study_id
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