Clinical trial • Phase II • Immunology

CIT-013 for Rheumatoid arthritis

Phase II trial of CIT-013 for Rheumatoid arthritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
21-03-2025
First CTIS Authorization Date
11-07-2025

Trial design

Randomised, placebo: 0.9% w/v sodium chloride injection bp (solution for injection), administered subcutaneously; investigational product: cit-013 administered subcutaneously with dose arms including 50 mg and 100 mg (three dose levels are studied; 50 mg and 100 mg arms are explicitly named and pooled for primary endpoint).-controlled Phase II trial across 25 sites in Germany, Poland, Belgium and others.

Randomised
Yes
Comparator
Placebo: 0.9% w/v Sodium Chloride Injection BP (solution for injection), administered subcutaneously; Investigational product: CIT-013 administered subcutaneously with dose arms including 50 mg and 100 mg (three dose levels are studied; 50 mg and 100 mg arms are explicitly named and pooled for primary endpoint).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
88
Trial Duration For Participant
85

Eligibility

Recruits 88 No vulnerable populations selected; participants must be ≥ 18 years and be willing and able to give written informed consent (no assent procedures described)..

Pregnancy Exclusion
Pregnant or lactating or planning to get pregnant during the duration of the trial.
Vulnerable Population
No vulnerable populations selected; participants must be ≥ 18 years and be willing and able to give written informed consent (no assent procedures described).

Inclusion criteria

  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- ≥ 18 years of age."}
  • {"criterion_text":"- Disease Activity Score ≥ 3.2 AND ≥ 3 Swollen Joints AND ≥ 3 Tender Joints, AND CRP/ESR ≥ upper limit of normal (ULN)."}
  • {"criterion_text":"- Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Female participants must agree to refrain from donating ova during the trial and for at least 31 weeks after the last dose of IP."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Body mass index is between 18 and 35 kg/m2, inclusive."}
  • {"criterion_text":"- Willing and able to give written informed consent."}

Exclusion criteria

  • {"criterion_text":"- Current inflammatory joint disease other than RA."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Prior use of >3 biological DMARD (bDMARD) or tsDMARD treatments."}
  • {"criterion_text":"- Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening."}
  • {"criterion_text":"- History of malignancy with exception of non-melanoma skin cancer that has been excised and cured."}
  • {"criterion_text":"- Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus infection, as tested and confirmed during screening"}
  • {"criterion_text":"- Pregnant or lactating or planning to get pregnant during the duration of the trial."}
  • {"criterion_text":"- Evidence of active tuberculosis (TB) or being at high risk for TB, assessed according to local site procedures."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- History of severe allergies, non-allergic drug reactions, or multiple drug allergies."}
  • {"criterion_text":"- Known hypersensitivity to any of the inactive ingredients of the trial treatment."}
  • {"criterion_text":"- Any other multi-system autoimmune disease."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Any other condition which, in the Investigator’s opinion will interfere with completion of the trial."}
  • {"criterion_text":"- Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this trial."}
  • {"criterion_text":"- 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."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean change in DAS28-CRP score from baseline to Day 43 comparing the pooled 50 mg and 100 mg CIT-013 arms versus placebo."}

Secondary endpoints

  • {"endpoint_text":"- Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings.","definition_or_measurement_approach":"Collection and tabulation of TEAEs (frequency and severity) across the trial period; safety assessment by investigators."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean change in DAS28-CRP from baseline to Day 43 and Day 85 measured separately for each randomized treatment arm."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of participants achieving ACR20/50/70 responses from baseline to Day 43 and Day 85 by treatment arm."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion achieving DAS28-CRP ≤3.2 (low disease activity) and <2.6 (remission) at Days 43 and 85 by arm."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean change in SDAI and CDAI from baseline to Days 43 and 85 per treatment arm."}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Mean change in HAQ-DI from baseline to Days 43 and 85 by arm."}
  • {"endpoint_text":"- 5.1. Pharmacokinetic (PK) levels throughout the trial, per arm of the originally assigned treatment.","definition_or_measurement_approach":"Measurement of CIT-013 PK levels at scheduled timepoints throughout the study per arm."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
88
Recruitment Window Months
16
Consent Approach
Written informed consent is required: participants must be willing and able to give written informed consent. Subject information pamphlets and informed consent forms are provided (documents available in multiple languages including English, Dutch, German, Polish, Spanish, French, Catalan and Galician where published) and pregnancy-specific ICFs are provided; assent is not applicable (participants are ≥18 years).

Methods

  • Site-based recruitment via participating hospitals/clinics and rheumatology centres listed as trial sites in each country (local site contact details provided per site).
  • Online/digital recruitment using Link2Trials recruitment materials and website text (country-specific Link2Trials materials and website text documents present for BE/PL/NL/ES).

Geography

Total Number Of Sites
25
Total Number Of Participants
88

Germany

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
16-07-2025
Processing Time Days
23
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Sozialstiftung Bamberg
Department Name
Praxis für Rheumatologie
Contact Person Name
Claudia Dechant
Site Name
Rheumatologische Schwerpunktpraxis
Department Name
Rheumatologische Schwerpunktpraxis
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de
Site Name
Prof. Herbert Kellner
Department Name
Rheumatologie
Contact Person Name
Herbert Kellner
Contact Person Email
hk@prof-dr-kellner.de
Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Department Name
Rheumazentrum Ratingen Studienambulanz
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Sektion Rheumatologie und klinische Immunologie – Studienambulanz
Contact Person Name
Hendrik Schulze-Koops

Poland

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
162
Number Of Sites
6
Number Of Participants
33

Sites

Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
Center for Treatment of Osteoarticular and Spine Diseases
Contact Person Name
Stefan Daniluk
Contact Person Email
daniluk@clinicmed.pl
Site Name
Reumed Sp. z o.o.
Department Name
Rheumatology Clinic
Contact Person Name
Dariusz Chudzik
Contact Person Email
dariuszbchudzik@wp.pl
Site Name
Medyczne Centrum Hetmanska Piotr Leszczynski
Department Name
Hetmanska Medical Center
Contact Person Name
Piotr Leszczynski
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Medicover Integrated Clinical Services
Contact Person Name
Sławomir Jeka
Contact Person Email
s.jeka@wp.pl
Site Name
Wsd Medi Clinical Sp. z o.o.
Department Name
Mediclinical
Contact Person Name
Aleksandra Juskiewicz
Contact Person Email
olaur@interia.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
All-Med
Contact Person Name
Grazyna Pulka
Contact Person Email
pulkaallmed@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
153
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Division of Rheumatology
Contact Person Name
Alla Ishchenko
Contact Person Email
alla.ishchenko@zas.be
Site Name
UZ Leuven
Department Name
Division of Rheumatology
Contact Person Name
Patrick Verschueren

Netherlands

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
215
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Maasstad Ziekenhuis Stichting
Department Name
Reumatologie en Klinische Immunologie
Contact Person Name
Radjesh Bisoendial
Site Name
Amsterdam UMC Stichting
Department Name
| Department of Rheumatology & Clinical Immunology
Contact Person Name
Sander Tas
Contact Person Email
s.w.tas@amsterdamumc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Polikliniek Reumatologie
Contact Person Name
Hanna van Steenbergen
Contact Person Email
h.w.van_steenbergen@lumc.nl
Site Name
Frisius MC
Department Name
Afdeling Reumatologie
Contact Person Name
Reinhart Bos
Contact Person Email
r.bos@frisiusmc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Reumatologie
Contact Person Name
Rogier Thurlings
Contact Person Email
Rogier.Thurlings@radboudumc.nl

Spain

Earliest CTIS Part Ii Submission Date
02-07-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
285
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
University Of A Coruna
Department Name
Catedrático de Reumatología
Contact Person Name
Francisco Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Universitario De La Princesa
Department Name
Jefa de Servicio de Reumatologia
Contact Person Name
Rosario García de Vicuña
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servei de Reumatologia
Contact Person Name
Maria Lopes Lasanta
Site Name
Instituto De Investigacion Marques De Valdecilla
Department Name
Reumatología
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
rblancovela@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Rheumatology Service (ICEMEQ) - Arthritis Unit
Contact Person Name
Beatriz Frade
Contact Person Email
FRADE@clinic.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Reumatología
Contact Person Name
José Andrés Román Ivorra
Contact Person Email
roman_jan@gva.es
Site Name
Universidade De Santiago De Compostela
Department Name
Jefe del Servicio de Reumatología
Contact Person Name
Eva Perez Pampin
Contact Person Email
eva.perez.pampin@sergas.es

Sponsor

Primary sponsor

Full Name
Citryll B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
CIT-013
Active Substance
CIT-013
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Starting Dose
50 mg
Dose Levels
50 mg|100 mg
Maximum Dose
600 mg (max total dose amount as reported)
Investigational Product Name
0.9% w/v Sodium Chloride Injection BP
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Marketing authorisation held (marketingAuthNumber: PL 03551/0076)
Maximum Dose
max daily: 1 ml; max total: 6 ml (as reported)

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