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Trial eligibility change
| eligibility_criteria | Key Inclusion Criteria: 1. For USA participants, age criteria are 4 to \< 18 years old, at the time of the administration of the first dose of study intervention. Non-USA participants age criteria are 2 to \< 18 years old 2. Must have a confirmation of FOP diagnosis, as described in the protocol 3. At the time of enrollment, participants must weight: 1. Cohort 1 \> 30 kg 2. Cohort 2 \> 30 kg 3. Cohort 3 ≤ 30 kg Key Exclusion Criteria: 1. Cumulative Analog Joint Involvement Scale (CAJIS) score \> 19 at the time of screening 2. Participant has significant concomitant illness or history of significant illness, as described in the protocol 3. Previous history or diagnosis of cancer 4. Ongoing significant viral or bacterial illness, within 2 weeks of the first study drug administration 5. History of severe respiratory compromise requiring oxygen, respiratory support 6. Known history of cerebral vascular malformation 7. Participants with a history of severe, non-traumatic bleeding requiring transfusion or hospitalization for hemodynamic compromise 8. Participants with a known pre-existing medical history of a bleeding diathesis, as described in the protocol NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply | → | Key Inclusion Criteria: 1. For USA participants, age criteria are 4 to \< 18 years old, at the time of the administration of the first dose of study intervention. Non-USA participants age criteria are 2 to \< 18 years old 2. Must have a confirmation of FOP diagnosis, as described in the protocol 3. At the time of enrollment, participants must weight: 1. Cohort 1: more than 30 kg (or 66.1 pounds) 2. Cohort 2: more than 30 kg (or 66.1 pounds) 3. Cohort 3: less than or equal to 30 kg (or 66.1 pounds) Key Exclusion Criteria: 1. Cumulative Analog Joint Involvement Scale (CAJIS) score \> 19 at the time of screening 2. Participant has significant concomitant illness or history of significant illness, as described in the protocol 3. Previous history or diagnosis of cancer 4. Ongoing significant viral or bacterial illness, within 2 weeks of the first study drug administration 5. History of severe respiratory compromise requiring oxygen, respiratory support 6. Known history of cerebral vascular malformation 7. Participants with a history of severe, non-traumatic bleeding requiring transfusion or hospitalization for hemodynamic compromise 8. Participants with a known pre-existing medical history of a bleeding diathesis, as described in the protocol 9. Participants who have used palovarotene in the last 30 days or within 5 half-lives of the therapy, whichever is longer from the day of randomization NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply |
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No other named entities identified.This event has no scored competitor read-through.
No real valuation-relevant phase transition on a resolved asset for this event.This section fires only when the event carries a resolved asset and a real phase change — not guessed for every event.