2025-522922-11-00RecruitingPhase 2
A trial to assess the efficacy and safety of ACT-1004-1239 in adults with progressive multiple sclerosis
A single-center, randomized, double blind, placebo-controlled, parallel-group, proof-of-concept trial to assess the efficacy and safety of ACT-1004-1239 in adults with progressive multiple sclerosis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Sept 2026
Brief summary (registry, in English)
To evaluate the effect of ACT-1004-1239, compared with placebo, on remyelination in participants with progressive MS, as measured by magnetic resonance imaging (MRI)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 3 Mar 2026
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Diseases
- Multiple sclerosis
- EU CT number
- 2025-522922-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 55 with primary or secondary progressive multiple sclerosis (MS) and no recent relapse.
- Age
- 18 to 55 years (the inclusion criteria say 18 to 55; the registry header lists a maximum age of 64).
- Sex
- Men and women can join.
- Disease stage
- Primary or secondary progressive MS, diagnosed by an MS-expert neurologist. EDSS score from 2.0 to 6.0. No clinical relapse in the 6 months before screening.
- Earlier treatment
- People already on a disease-modifying therapy must have been on a stable dose for at least 6 months before screening.
Main reasons for not taking part
- Cannot have MRI scans or lumbar punctures
- Other nerve or autoimmune disorders that could interfere with the trial
- Cancer in the last 5 years (with a few skin and cervical exceptions)
- Active infection or a major infection needing hospital or antibiotic treatment recently
- Pregnant, breastfeeding or planning pregnancy during the trial
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active bacterial, viral, fungal, mycobacterial infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to Screening or with oral antibiotics within 2 weeks prior to Screening
- Not able or willing to stop treatment with moderate or strong CYP3A4 inhibitors or inducers from at least 4 weeks prior to randomization (i.e., at Visit 2)
- Receipt of a live (or live attenuated) vaccine within 6 weeks prior to randomization (i.e., 2 weeks prior to Visit 2)
Other illness
- Known history or presence of other neurologic or systemic autoimmune disorders that are assessed by the investigator to potentially interfere with the collection of data or safety of the participant
- History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
Other
- Inability to comply with MRI scanning or undergo lumbar punctures
- Female participants: pregnant, lactating or planning to become pregnant during the trial (i.e., until 30 days after permanent discontinuation of trial intervention)
Who the study is looking for
- Male or female, aged ≥18 to ≤55 years
- Diagnosis of primary or secondary progressive MS according to the 2013 revisions of clinical course of MS and the 2017 revisions of the McDonald criteria by an MS- expert neurologist prior to Screening.
- Absence of clinical relapse within 6 months prior to Screening
- Expanded disability status scale (EDSS) score ≥ 2.0 to ≤ 6.0
- If currently on disease-modifying therapy (DMT), it should be stable for ≥ 6 months prior to Screening
- For participants of childbearing potential: – Agreement to undertake monthly urine or serum pregnancy tests during the trial and up to 30 days after discontinuation of trial intervention – Agreement to use a highly effective method of contraception from Screening up to 30 days after discontinuation of trial intervention
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Human Drug Research | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.