A trial to assess the efficacy and safety of ACT-1004-1239 in adults with progressive multiple sclerosis
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Hollandia
- Centre for Human Drug ResearchLeiden, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Idorsia Pharmaceuticals Ltd.
- Trial code
- EU 2025-522922-11-00
- Record updated
- 2026. szeptember 14.
- Original description
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)Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: 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); 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); 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).