WHO ICTRP trial
Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of…
EUCTR2021-005314-34-BE · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2021-005314-34-BE |
|---|---|
| Public title | Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or Risdiplam |
| Scientific title | Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE |
| Primary sponsor | Scholar Rock, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;France;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy |
| Conditions | Spinal Muscular Atrophy (SMA) MedDRA version: 20.1 Level: LLT Classification code 10041583 Term: Spinal muscular atrophy, unspecified System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal… |
| Interventions | Product Name: Apitegromab Product Code: SRK-015 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Apitegromab CAS Number: 2278276-46-1 Current Sponsor code: SRK-015 Concentration unit: mg/ml milligram(s)/millilitre… |
| Registration date | Nov 2, 2022 |
| Target size | 204 |
| Secondary IDs | SRK-015-003;NCT05156320;136872 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: