Phase 3, 52-week Study Evaluating Rocatinlimab (AMG451)in Adolescent Subjects With Moderate-to-severe AD (ROCKET-ASTRO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

15 May 2023 → 25 Nov 2025

Decision date (initial)

2023-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc.

External identifiers

EU CT number

2022-501586-50-00

WHO UTN

U1111-1282-8776

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

To evaluate the efficacy of rocatinlimab compared with placebo at week 24
To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using Eczema Area and Severity Index (EASI)

Secondary objectives 6

1. To evaluate the efficacy of rocatinlimab compared with placebo, assessed using EASI
2. To evaluate the efficacy of rocatinlimab compared with placebo.
3. To evaluate the efficacy of rocatinlimab compared with placebo on the patient-reported outcome (PRO) measure of pruritus
4. To evaluate the efficacy of rocatinlimab compared with placebo at week24, assessed using EASI
5. To evaluate the efficacy of rocatinlimab compared with placebo at week24 on the PRO measure of atopic dermatitis (AD) skin pain
6. To evaluate the efficacy of rocatinlimab compared with placebo at week 24 with an additional assessment of morphology

Conditions and MedDRA coding

Atopic Dermatitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002886-PIP01-20

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05704738) and on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Males and females age ≥12 to <18 years at day 1 with a 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.
2. Prior to informed consent, history of inadequate response to TCS of medium to higher potency (with or without TCI as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to pre-determined score) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for maximum duration recommended by the product prescribing information (eg, 14 days for super-high potent TCS), whichever is shorter. Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
3. Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, (on the pre-determined score) Additionally, EASI score ≥ 12 at initial screening and EASI score ≥ 16 at day 1 prerandomization; patient-reported worst pruritus NRS pre-determined score based on a single-question item with 7-day recall is required at initial screening

Exclusion criteria 3

1. Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
2. 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.
3. Treatment with any of the following medications or therapies within 1 week, prior to Day 1: Topical Corticosteroids, Topical Calcineurin Inhibitors, Topical phosphodiesterase type 4 inhibitors, Other topical immunosuppressive agents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Achieving a pre-determined score at week 24
2. Achieving a pre-determined score at week 24

Secondary endpoints 6

1. Achieving a pre-determined score
2. Achieving a pre-determiend score
3. Achieving a pre-determined score from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score in subjects with baseline weekly average of daily worst pruritus NRS score Achieving a pre-determined score 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. Achieving a pre-determined reduction from baseline in EASI at week 24
5. Achieving a pre-determined score from baseline in weekly average of AD skin pain NRS score at week 24 in subjects with baseline weekly average of AD skin pain NRS
6. Achieving a pre-determined score with presence of only barely perceptible erythema at week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 12

Locations

10 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Documents 229 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications