Repair effects of leramistat in participants with rheumatoid arthritis
| ISRCTN | ISRCTN16456769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16456769 |
| Integrated Research Application System (IRAS) | 1012675 |
| Central Portfolio Management System (CPMS) | 69387 |
| Protocol serial number | IST-03 |
| Sponsor | Istesso Therapeutics |
| Funder | Istesso Therapeutics |
- Submission date
- 30/04/2026
- Registration date
- 01/05/2026
- Last edited
- 03/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date
Contact information
Public, Scientific, Principal investigator
Newcastle upon Tyne Hospitals NHS Trust
Newcastle upon Tyne
NE1 4LP
United Kingdom
| Phone | 44 (0)191 213 7118 |
|---|---|
| John.Isaacs@newcastle.ac.uk |
Public, Scientific
3 Pancras Square
London
N1C 4AG
United Kingdom
| patrick@istesso.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | A randomised, double-blind, placebo-controlled trial of the effects of leramistat (MBS2320) on muscle in participants with rheumatoid arthritis |
| Study objectives | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Ethics approval(s) |
Approved 07/10/2025, East of England - Essex Research Ethics Committee (2 Redman Place, London, EC20 1JQ, United Kingdom; +44 2071048106; approvals@hra.nhs.uk), ref: 25/EE/0186 |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | leramistat |
| Primary outcome measure(s) |
The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Key secondary outcome measure(s) |
The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Completion date | 09/09/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Key exclusion criteria | The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date |
| Date of first enrolment | 20/04/2026 |
| Date of final enrolment | 29/01/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
03/06/2026: Internal review.
30/04/2026: Trial's existence confirmed by East of England - Essex Research Ethics Committee.
