AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

This study is looking into a new medicine called OM336. It's for adults (18 years and older) who have Sjögren’s disease or idiopathic inflammatory myopathy. Both men and women can join. This is an early-stage study, which means researchers are mainly trying to understand how OM336 works in the human body, how safe it is, and what dose might be best. It's called an 'open-label' study, so everyone involved will know they are receiving the study medicine. The aim is to find out more about this potential treatment for these conditions, which affect the immune system and can cause dryness, tiredness, or muscle weakness.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ouro Medicines Limited

Enrolment target

Start

21 Apr 2026

Seropositive autoimmune disease: Sjogren’s disease or idiopathic inflammatory myopathy

What is this study about?

This study is an early research project for a new medicine named OM336. It's designed for people who have certain autoimmune conditions: Sjögren’s disease or idiopathic inflammatory myopathy. Autoimmune diseases happen when your body's immune system mistakenly attacks its own healthy tissues.

For people with Sjögren’s disease, this often means problems like very dry eyes and mouth, as well as tiredness and joint pain. Idiopathic inflammatory myopathy leads to muscle weakness and inflammation. Currently, there isn't a cure for these conditions, and treatments focus on managing symptoms.

The main goal of this study is to explore how the new medicine, OM336, behaves in the body and to determine if it is safe for people with these conditions. Researchers are also trying different amounts (doses) of the medicine to see what works best and has the fewest side effects. Since it's an 'open-label' study, participants will know they are receiving the actual study medicine, not a dummy treatment.

Key takeaways

This is an early study of a new medicine, OM336, for Sjögren’s disease and idiopathic inflammatory myopathy.
The main aims are to check safety and how the medicine works in the body.
Adults aged 18 and over, both men and women, can potentially join.
You will know you are receiving the active study medicine.
Participation involves regular clinic visits and health checks.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, so older adults can also take part. We welcome both men and women to join.

To be considered for this study, you must have been diagnosed with either Sjögren’s disease or idiopathic inflammatory myopathy. Doctors will check your medical records to confirm this.

There will be other health checks and rules to make sure the study is safe for you and that the results are clear. For example, doctors will look at your overall health and any other medicines you take. These details will be discussed fully if you express an interest.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Sjögren’s disease?
OR have you been diagnosed with idiopathic inflammatory myopathy?
Are you able to travel to the study clinic for appointments?
Are you willing to follow the study procedures, including regular blood tests and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if it's right for you. This will involve health checks, blood tests, and scans. If you qualify, you'll then regularly visit the clinic. During these visits, you'll receive the study medicine, OM336, as tablets or injections, depending on the dose group you are in. You'll also have blood tests and other examinations to see how you're reacting to the medicine and to check for any side effects.

The study involves multiple doses, meaning you'll receive the medicine over a period. The total length of the study will vary for each person, but it will involve regular check-ups and follow-up visits after you finish taking the medicine. All your travel costs to the clinic will be covered, and you'll have a dedicated team to support you throughout.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that OM336 helps improve your Sjögren’s disease or idiopathic inflammatory myopathy symptoms, although this is not guaranteed as it's an early-stage study. You'll also be helping researchers learn more about these conditions and develop future treatments. Potential risks include side effects from the study medicine, which could be mild or more serious, or the possibility that the medicine may not help your condition. All risks will be fully explained before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What are Sjögren’s disease and idiopathic inflammatory myopathy?

These are conditions where your body's immune system mistakenly attacks its own healthy tissues, leading to symptoms like dryness, tiredness, or muscle weakness.

What does 'Phase 1b' mean?

It means this is an early stage of human testing. The main goals are to check if the medicine is safe and how it works in the body, and to find the best dose.

Will I know if I'm getting the real medicine?

Yes, this is an 'open-label' study, so everyone in the study will know they are receiving the study medicine, OM336.

How long will the study last if I join?

The exact duration will vary for each participant, but it involves several visits for treatment and follow-up after the medicine stops. The study team will provide more details.

Do I have to pay to be in the study?

No, all study-related medical care and the investigational medicine will be provided at no cost, and your travel expenses to the clinic will be covered.