Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND) (ROCKET-ASCEND)
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
mai 2023
mai 2027
23 mai 2025
The primary objective of this study is to describe the long-term safety and tolerability
of rocatinlimab in participants with moderate-to-severe AD.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Cabinet du Docteur Ruer-Mulard Mireille - 13500 - Martigues - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Bretagne Sud - Hopital du Scorff - 56322 - Lorient Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Archet 2 - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou - 35033 - Rennes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive d Antony - 92160 - Antony - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75475 - Paris Cedex 10 - France | Contact (sur clinicalTrials) | ||||
| Polyclinique de Courlancy - 51430 - Bezannes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult
or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE,
ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER)
within the past 28 days.
- Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI
score at week 52 of at least 60% compared to parent study baseline (EASI 60).
- Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult
or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE,
ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER)
within the past 28 days.
- Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI
score at week 52 of at least 60% compared to parent study baseline (EASI 60).
- Permanent investigational product discontinuation due to safety-related reasons,
protocol-defined stopping rules or conditions/reasons unrelated to efficacy during
the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE,
ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day
1.