A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Official Title
-----------------
A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Rocatinlimab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI]). EASI score ≥16 vIGA-AD score ≥3 ≥10% body surface area (BSA) of AD involvement Worst pruritus numerical rating scale ≥ 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: Systemic corticosteroids Systemic immunosuppressants Phototherapy Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS of any potency TCI Topical phosphodiesterase type 4 inhibitors Other topical immunosuppressive agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2 | Drug: Rocatinlimab<br>* Participants will receive Rocatinlimab subcutaneously.<br>* Other names: AMG 451;|
| Experimental: Arm B<br>Rocatinlimab Dose 2 Q4W + loading dose at Week 2 | Drug: Rocatinlimab<br>* Participants will receive Rocatinlimab subcutaneously.<br>* Other names: AMG 451;|
| Placebo Comparator: Arm C<br>Placebo Q4W+ loading dose at Week 2 | Drug: Placebo<br>* Participants will receive a placebo subcutaneously.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24 |  | Baseline, Week 24 | 
| Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of ≥75% reduction from baseline in EASI score at Week 16 |  | Baseline, Week 16 | 
| Achievement of a vIGA-AD score of 0 or 1 from baseline at week 16 |  | Baseline, Week 16 | 
| Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4 |  | Baseline, Week 16 | 
| Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4 |  | Baseline, Week 24 | 
| Achievement of ≥90% reduction from baseline in EASI score at Week 24 |  | Baseline, Week 24 | 
| Change from baseline in DLQI score at week 24 |  | Baseline, Week 24 | 
| Change from baseline in weekly average of daily AD skin pain NRS score at week 24 |  | Baseline, Week 24 | 
| Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24 |  | Baseline, Week 24 | 
| Achievement of ≥ 4-point reduction from baseline in DLQI score at week 24 in subjects with baseline DLQI score ≥ 4 |  | Baseline, Week 24 | 
| Achievement of ≥ 4-point reduction from baseline in POEM score at week 24 in subjects with baseline POEM score ≥ 4 |  | Baseline, Week 24 | 
| Change from baseline in POEM score at week 24 |  | Baseline, Week 24 | 
| Change from baseline in weekly average of daily AD skin pain NRS score at week 16 |  | Baseline, Week 16 | 
| Change from baseline in weekly average of daily sleep disturbance NRS score at week 24 |  | Baseline, Week 24 | 
| Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8 |  | Baseline, Week 24 | 
| Change from baseline in HADS-anxiety subscale score at week 24 |  | Baseline, Week 24 | 
| Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8 |  | Baseline, Week 24 | 
| Change from baseline in HADS-depression subscale score at week 24 |  | Baseline, Week 24 | 
| Achievement of Facial AD Severity Score of Clear at week 24 for subjects with facial AD at baseline |  | Baseline, Week 24 | 
| Achievement of Hand AD Severity Score of Clear at week 24 for subjects with hand AD at baseline |  | Baseline, Week 24 | 
| Achievement of Genital AD Severity Score of Clear at week 24 for subjects with genital AD at baseline |  | Baseline, Week 24 | 
| Change from baseline in weekly average of daily worst pruritus NRS score at week 16 |  | Baseline, Week 16 | 
| Change from baseline in weekly average of daily worst pruritus NRS score at week 24 |  | Baseline, Week 24 | 
| Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at week 16 |  | Baseline, Week 16 | 
| Change from baseline in SCORAD itch VAS score at week 24 |  | Baseline, Week 24 | 
| Achievement of ≥ 8.7-point reduction from baseline in SCORAD score at week 24 in participants with baseline SCORAD score ≥ 8.7 |  | Baseline, Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab