Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
3
Sites
6
systemic lupus erythematosus [SLE]/lupus nephritis [LN], idiopathic inflammatory myopathy [IIM], and diffuse cutaneous systemic sclerosis [DcSSc]
Key facts
- Sponsor
- Century Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 10 Jul 2025 → 7 May 2026
- Decision date (initial)
- 2025-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518797-13-00
- ClinicalTrials.gov
- NCT06255028
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
systemic lupus erythematosus [SLE]/lupus nephritis [LN], idiopathic inflammatory myopathy [IIM], and diffuse cutaneous systemic sclerosis [DcSSc]
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10012977 | Diffuse systemic sclerosis | 10028395 |
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Century Therapeutics Inc.
- Sponsor organisation
- Century Therapeutics Inc.
- Address
- 25 North 38th Street Fl 11
- City
- Philadelphia
- Postcode
- 19104-5640
- Country
- United States
Scientific contact point
- Organisation
- Century Therapeutics Inc.
- Contact name
- Century Therapeutics Clinical Team
Public contact point
- Organisation
- Century Therapeutics Inc.
- Contact name
- Century Therapeutics Clinical Team
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 4 | 3 |
| Germany | Ended | 8 | 1 |
| Italy | Ended | 4 | 2 |
| Rest of world
United States
|
— | 24 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Département de médecine interne, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Les Hopitaux Universitaires De Strasbourg
Service d’Immunologie Clinique, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Les Hopitaux Universitaires De Strasbourg
Service de Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Johannes Wesling Klinikum Minden
Department of rheumatologyand clinical immunology, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-07-10 | 2025-10-22 | 2025-11-04 | ||
| Germany | 2025-08-06 | 2025-09-11 | 2025-11-04 | ||
| Italy | 2025-10-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-07-31
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-07-31
- Immediate action required
- Yes
- Notes
- Reverted (2025-07-31)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2024-518797-13-00 procedure (AIFA authorization provision n° 86867);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | Germany | Acceptable 2025-04-14
|
2025-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-22 | Germany | Acceptable | 2025-07-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-23 | Acceptable | 2025-07-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-23 | Acceptable | 2025-06-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-03 | Germany | Acceptable 2025-11-17
|
2025-11-17 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | Germany | Acceptable 2025-11-17
|
2025-12-19 |