Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO) (ROCKET-ASTRO)
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
avril 2023
novembre 2025
12 décembre 2024
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in
monotherapy and combination therapy treatment in adolescent participants.
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 | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Regional Universitaire Brest Hopital Morvan - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes Hôtel Dieu - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou - 35033 - Rennes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Toulouse, Hopital Larrey - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive d Antony - 92160 - Antony - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Joseph - 13285 - Marseille Cedex 8 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 12 to < 18 years at Day 1.
- Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria
[Eichenfield et al, 2014]) that has been present for at least 12 months before
signing of informed consent.
- Body weight ≥ 40 kg at screening.
- History of inadequate response to TCS of medium to higher potency (with or without
TCI).
- EASI score ≥ 12 at initial screening.
- EASI score ≥ 16 at Day 1.
- vIGA-AD score ≥ 3.
- ≥10% body surface area of AD involvement.
- Worst pruritus NRS ≥ 4.
- Age ≥ 12 to < 18 years at Day 1.
- Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria
[Eichenfield et al, 2014]) that has been present for at least 12 months before
signing of informed consent.
- Body weight ≥ 40 kg at screening.
- History of inadequate response to TCS of medium to higher potency (with or without
TCI).
- EASI score ≥ 12 at initial screening.
- EASI score ≥ 16 at Day 1.
- vIGA-AD score ≥ 3.
- ≥10% body surface area of AD involvement.
- Worst pruritus NRS ≥ 4.
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is
longer, prior to Day 1.
- Treatment with any of the following medications or therapies within 4 weeks or 5
half-lives, whichever is longer, prior to Day 1:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to
Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents