Proof of Concept trial with CIT-013 in Rheumatoid Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Citryll B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

29 Jul 2025 → ongoing

Decision date (initial)

2025-07-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517356-35-00

ClinicalTrials.gov

NCT06567470

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Efficacy

The primary objective of this trial is to evaluate the efficacy of CIT-013 in patients with moderately active RA.

Secondary objectives 5

1. Describe the safety and tolerability of CIT-013 in patients with moderately active RA.
2. Evaluate the efficacy of CIT-013 in patients with moderately active RA, per dose level.
3. Evaluate the effect of CIT-013 on disease activity in patients with moderately active RA.
4. Evaluate the effect of CIT-013 on patient reported health assessment in patients with moderately active RA
5. Characterize pharmacokinetic profile of CIT-013 in patients with moderately active RA.

Conditions and MedDRA coding

Moderately Active Rheumatoid Arthritis

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, Medicines Evaluation Board, Paul-Ehrlich-Institut, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 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 (diagnosis based on medical records).
2. ≥ 18 years of age.
3. Disease Activity Score ≥ 3.2 AND ≥ 3 Swollen Joints AND ≥ 3 Tender Joints, AND CRP/ESR ≥ upper limit of normal (ULN).
4. Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
5. Agree to use adequate contraception during the trial for women of childbearing potential (WOCBP), and for 31 weeks after the last dose of IP, and must have a negative pregnancy test prior to entry into the trial. Whether female participants are of childbearing potential needs to be evaluated according to the criteria in Annex 4. Contraceptive Guidance.
6. Female participants must agree to refrain from donating ova during the trial and for at least 31 weeks after the last dose of IP.
7. Agree to use adequate contraception and refrain from donating sperm during the trial, and for 18 weeks after the last dose of IP, for male participants.
8. Body mass index is between 18 and 35 kg/m2, inclusive.
9. Willing and able to give written informed consent.

Exclusion criteria 18

1. Current inflammatory joint disease other than RA.
2. Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening or expected to be in need of this during the active part of the trial.
3. History of severe allergies, non-allergic drug reactions, or multiple drug allergies.
4. Known hypersensitivity to any of the inactive ingredients of the trial treatment.
5. Any other multi-system autoimmune disease.
6. Significant clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, at discretion of the Investigator (or designee).
7. Any other condition which, in the Investigator’s opinion will interfere with completion of the trial.
8. Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this trial.
9. Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
10. Use of bDMARD or tsDMARD prior to the first dose of IP, unless the washout period for bDMARDs or tsDMARD prior to the first dose of IP is at least: e) ≥ 2 weeks for etanercept; f) ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; g) ≥ 6 months for rituximab; h) ≥ 1 week of a targeted synthetic DMARD (tsDMARD).
11. Prior use of >3 biological DMARD (bDMARD) or tsDMARD treatments.
12. Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
13. History of malignancy with exception of non-melanoma skin cancer that has been excised and cured.
14. Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus infection, as tested and confirmed during screening
15. Pregnant or lactating or planning to get pregnant during the duration of the trial.
16. Evidence of active tuberculosis (TB) or being at high risk for TB, assessed according to local site procedures.
17. History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis, as reported by participants.
18. High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the mean change in DAS28-CRP, from baseline to day 43, of CIT-013 the 50 mg CIT-013 and 100 mg CIT-013 arms pooled, compared to placebo.

Secondary endpoints 7

1. Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings.
2. 2.1. Mean change in DAS28-CRP, from baseline to day 43, per arm of the originally assigned treatment. 2.2. Mean change in DAS28-CRP, from baseline to day 85, per arm of the originally assigned treatment.
3. 3.1. Proportion of ACR20, ACR50, ACR707 responders, from baseline to day 43, per arm of the originally assigned treatment. 3.2. Proportion of ACR20, ACR50, ACR70 responders, from baseline to day 85, per arm of the originally assigned treatment.
4. 3.3. Proportion of participants reaching low disease activity, defined as DAS28-CRP equal or less than 3.2, from baseline to day 43 and day 85, per arm of the originally assigned treatment. 3.4. Proportion of participants reaching disease remission, defined as DAS28-CRP less than 2.6, from baseline to day 43 and day 85, per arm of the originally assigned treatment.
5. 3.5. Mean change in Simplified Disease Activity Index for RA (SDAI) and Clinical Disease Activity Index (CDAI) scores, from baseline to day 43, per arm of the originally assigned treatment. 3.6. Mean change in SDAI and CDAI scores, from baseline to day 85, per arm of the originally assigned treatment.
6. 4.1. Mean change in Health Assessment Questionnaire Disability Index (HAQDI), from baseline to day 43, per arm of the originally assigned treatment. 4.2. Mean change in HAQDI scores, from baseline to day 85, per arm of the originally assigned treatment.
7. 5.1. Pharmacokinetic (PK) levels throughout the trial, per arm of the originally assigned treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Citryll B.V.

Sponsor organisation

Citryll B.V.

Address

Re Gebouw, Kloosterstraat 9 Kloosterstraat 9

City

Oss

Postcode

5349 AB

Country

Netherlands

Scientific contact point

Organisation

Citryll B.V.

Contact name

Maarten Kraan

Public contact point

Organisation

Citryll B.V.

Contact name

Sjoerd van Gorp

Locations

5 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 98 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications