Phase 3 Transverse Myelitis Trial, Recruiting NCT05199688 Sponsor: Hoffmann-La Roche Condition: Transverse Myelitis
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Phase 3 Transverse Myelitis Trial, Recruiting

NCT05199688
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children between 2 and 11 years old (inclusive) at the time of screening
  • Children who weigh at least 10 kg (approximately 22 pounds) at the time of screening
  • Girls who have started their periods must agree to either avoid sexual intercourse or use reliable birth control during the trial
  • Diagnosed with a condition called NMOSD (a disease that affects the spinal cord and optic nerves) with a specific positive blood marker called AQP4 antibody, based on recognised medical criteria
  • Has had at least one recorded episode (attack) of the condition in the year before screening, including a first-ever attack
  • Neurological condition has been stable for at least 30 days before both the screening visit and the start of the trial
  • Disability level falls within a specific range on a standard scale (score 0 to 6.5) (confirm with trial site)
  • If already taking an immune-suppressing medication and planning to continue it, the dose must have been unchanged for at least 4 weeks before the trial starts

Who may not be able to join:

  • Girls or women who are pregnant or currently breastfeeding
  • Shows signs of another condition that looks similar to NMOSD but is a different disease affecting the nervous system
  • Has an active or recurring infection (bacterial, viral, fungal, or other) at the start of the trial
  • Has evidence of long-term active hepatitis B or hepatitis C (liver infections)
  • Has untreated tuberculosis (TB), whether hidden (latent) or active
  • Has received a live or live-attenuated vaccine (a type of vaccine using a weakened live virus) within 6 weeks before the trial starts
  • Has a history of a severe allergic reaction to a biologic medicine (a type of medication made from biological sources)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S.)

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
6 May 2026
Est. completion
31 March 2027

Where this trial is recruiting

🇦🇷 Argentina 🇨🇳 China 🇫🇷 France 🇮🇹 Italy 🇲🇽 Mexico 🇵🇱 Poland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Summary of observed serum concentration [Cthrough] of satralizumab; Apparent clearance [CL/F] of satralizumab; Apparent volume of distribution [V/F] of satralizumab; Area under the concentration-time curve [AUC] of satralizumab

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov