OM336 in seropositive autoimmune diseases
| ISRCTN | ISRCTN16355728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16355728 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2025-524100-29-00 |
| Protocol serial number | OM336-SAI-1002 |
| Sponsor | Ouro Medicines Ltd. |
| Funder | Ouro Medicines, Ltd. |
- Submission date
- 09/10/2025
- Registration date
- 22/10/2025
- Last edited
- 15/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This is a Phase 1b clinical study testing an investigational medicine called OM336 in adults with either Sjögren’s disease (SjD) or idiopathic inflammatory myopathy (IIM). These are autoimmune diseases where the body’s immune system attacks its own tissues, causing long-term inflammation, pain, and fatigue.
The purpose of this study is to find out whether OM336 is safe and well-tolerated when given to people with active SjD or IIM. The study will also help researchers understand how the body responds to OM336 and whether it improves disease symptoms.
Who can participate?
Patients with a diagnosis of active seropositive autoimmune disease between 18 and 75 years of age.
What does the study involve?
Everyone enrolled will receive the study drug—there is no placebo group. Participants will be closely monitored through medical exams, blood and urine tests, and regular check-ups over approximately a year.
What are the possible benefits and risks of participating?
OM336 is still an experimental drug, so its benefits and risks are not fully known. Early research suggests it may help control the overactive immune system and reduce the need for other medications such as steroids. The most common risks relate to immune suppression and possible infection. Doctors will monitor participants carefully and may prescribe antibiotics or other medicines if needed.
Where is the study run from?
Ouro Medicines Ltd.
When is the study starting and how long is it expected to run for?
August 2025 to March 2028
Who is funding the study?
Ouro Medicines Ltd.
Who is the main contact?
clinical@ouromeds.com
Contact information
Public, Scientific, Principal investigator
1 Ashley Road
3rd Floor
Altrincham
Cheshire
WA142DT
United Kingdom
| Phone | +1 415-429-4887 |
|---|---|
| clinical@ouromeds.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label multicenter multiple-ascending-dose study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | An open-label, phase 1b, multiple ascending dose study of OM336 in participants with active Sjogren’s disease or idiopathic inflammatory myopathy |
| Study objectives | An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. |
| Ethics approval(s) |
1. Approved 22/09/2025, Northern A Health and Disability Ethics Committee (HDEC) (New Zealand Ministry of Health, PO Box 5013, Wellington, 6140, New Zealand; -; hdecs@health.govt.nz), ref: 2025 FULL 23606 2. Submitted 06/08/2025, Department of Health WA Human Research Ethics Committee (DoH HREC) (PO Box 8172, Perth Business Centre, Perth, 9849, Australia; +61 8 9222 4214; hrec@health.wa.gov.au), ref: 2025-09-1433 |
| Health condition(s) or problem(s) studied | Sjogren’s Disease (SjD), Idiopathic Inflammatory Myopathy (IIM) |
| Intervention | Generic drug name / active substance: OM336 (INN pending; recombinant humanized bispecific antibody directed at BCMA and CD3). Treatment Arms OM336 is administered in 3 multiple ascending dose (MAD) cohorts and 3 expansion cohorts as summarized below: Cohorts / Treatment Arms: • Cohort A1: 5 participants (lowest dose) • Cohort A2: 5 participants (intermediate dose) • Cohort A3: 5 participants (highest dose) • Cohorts B1–B3: Expansion cohorts (up to 8 participants each) at the corresponding dose levels of A1–A3 once safety and tolerability at that dose level are confirmed. Dose and administration: OM336 is administered once weekly by subcutaneous (SC) injection as four fractionated, step-up injections. Dosing regimen: • Week 1 (Day 1): lowest dose • Week 2 (Day 8 ± 2 days): intermediate dose • Week 3 (Day 15 ± 2 days): target dose • Week 4 (Day 22 ± 2 days): repeat target dose Dose levels differ by cohort and are determined from prior safety data. All participants receive active drug. Post-treatment care / concomitant prophylaxis: Investigators may prescribe antibiotic or antiviral prophylaxis according to local guidelines. Intravenous immunoglobulin (IVIg) replacement may be given. Follow-up period: Participants are followed for approximately 52 weeks after the first dose, with regular site visits for clinical exams, laboratory monitoring, and pharmacokinetic/immunogenicity sampling. Randomization and blinding: None — this is an open-label, non-randomized study; all participants receive active OM336. Duration of entire intervention period: Up to four weeks of screening + four weeks of dosing + 48 weeks of safety follow-up = total ~56 weeks per participant. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | OM336 |
| Primary outcome measure(s) |
Safety and tolerability, defined as the incidence and severity of treatment-emergent adverse events (TEAEs) measured through participant reports, clinical assessments, and laboratory tests, and graded for severity using CTCAE at 12 weeks |
| Key secondary outcome measure(s) |
1. Safety and tolerability, defined as the incidence and severity of treatment-emergent adverse events (TEAEs), measured through participant reports, clinical assessments, and laboratory tests, and graded for severity using CTCAE at 52 weeks |
| Completion date | 01/03/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 39 |
| Key inclusion criteria | 1. Diagnosis of active seropositive autoimmune disease 2. Relapsed/refractory after ≥2 prior/ongoing treatments 3. Body weight ≥ 50 kg 4. Willing to comply with and study requirements and procedures |
| Key exclusion criteria | 1. Previous treatment with a BCMA-targeted therapy 2. Clinically significant infection within 3 months of screening 3. Major surgery within 3 months of screening or planned during the study 4. Pregnant or breastfeeding |
| Date of first enrolment | 30/11/2025 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- Australia
- New Zealand
Study participating centres
3204
New Zealand
2605
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/10/2025: Study's existence confirmed by the Northern A Health and Disability Ethics Committee (HDEC), New Zealand.
