A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Purpose

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Dose 1 		Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
Experimental
Arm B: Dose 2 		Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
Experimental
Arm C: Placebo 		Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).
  • Drug: Placebo
    SC injection
Experimental
Arm D: Open-Label Dose 1 		Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com