Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tyruko Injectable Product · 1 trial · 2 indications
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...
Tyruko Injectable Product is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is currently in Phase 2 clinical development, with an ongoing trial evaluating its use in people with inflammatory demyelination suggestive of Multiple Sclerosis, or definite Multiple Sclerosis, at first presentation.
Tyruko Injectable Product is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting a Phase 2 clinical trial of the drug in patients with Multiple Sclerosis.
Tyruko Injectable Product is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants with Multiple Sclerosis or clinically isolated syndrome suggestive of demyelination.
Tyruko Injectable Product is being studied in one active Phase 2 clinical trial with the identifier NCT05418010. This randomized, double-blind, placebo-controlled trial, titled AttackMS, enrolls approximately 40 participants in the United Kingdom and is investigating the drug in patients with Multiple Sclerosis or clinically isolated syndrome.
Tyruko Injectable Product is being studied in a trial that uses natalizumab as the treatment under investigation. The trial title references natalizumab for the treatment of inflammatory demyelination suggestive of Multiple Sclerosis. However, the drug name Tyruko Injectable Product is the name used in this development program.