Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05418010 | Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) | PHASE2 | RECRUITING | 40 | — | — | Dec 1, 2022 | Oct 31, 2027 | Jan 7, 2026 | 2 | United Kingdom |
Mean magnetisation transfer ratio (MTR) change in FLAIR-hyper-intense lesions at 12 weeks compared to baseline
| Arm | Type | Description |
|---|---|---|
| Tyruko® 300mg | ACTIVE_COMPARATOR | Tyruko® 300mg, administered via intravenous infusion in a 4 week cycle, for a total of 6 cycles |
| Placebo | PLACEBO_COMPARATOR | Placebo, administered via intravenous infusion in a 4 week cycle, for 3 cycles, followed by Tyruko® 300mg, administered via intravenous infusion for a total of 3 cycles |
| Name | Type | Description |
|---|---|---|
| Tyruko Injectable Product | DRUG | Tyruko® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tyruko® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tyruko® 300mg will be colourless, clear to slightly opalescent solution. |
| Placebo | DRUG | Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tyruko® minus the active ingredient. Placebo is in the same containers/vials as Tyruko®. |
Inclusion Criteria: 1. Participant has provided informed consent. 2. Age 18-55 years 3. Participant with CIS or MS at first presentation. 4. Participants show two or more lesions on T2 weighted MRI suggestive of demyelination. 5. Participant is willing and able to comply with clinical visits and pr...