A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe AD (ROCKET-Horizon)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

25 Apr 2023 → 18 Jun 2025

Decision date (initial)

2023-03-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2022-501538-44-00

WHO UTN

U1111-1281-5380

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

To compare the effect of rocatinlimab with placebo at week 24, using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD)(TM)

To compare the effect of rocatinlimab with placebo at week 24, using Eczema Area and Severity Index (EASI)

Secondary objectives 9

1. To compare the effect of rocatinlimab with placebo at week 16, using EASI
2. To compare the effect of rocatinlimab with placebo at week 16, using vIGA-AD
3. To compare the effect of rocatinlimab with placebo at weeks 16 and 24 on skin itching based on participant’s daily scoring
4. To compare the effect of rocatinlimab with placebo at week 24, using EASI
5. To compare the effect of rocatinlimab with placebo at week 24, assessed using vIGA-AD with an additional measurement
6. To compare the effect of rocatinlimab with placebo on facial eczema at week 24
7. To compare the effect of rocatinlimab with placebo on hand eczema at week 24
8. To compare the effect of rocatinlimab with placebo on genital eczema at week 24
9. To compare the effect of rocatinlimab with placebo at week 24 on the patient reported outcome measure of Dermatology Life Quality Index (DLQI)

Conditions and MedDRA coding

Atopic Dermatitis

Study design 1 period

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/NCT05651711) and on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
2. History of inadequate response to certain previous medications for the treatment of atopic dermatitis
3. EASI score ≥16
4. vIGA-AD score ≥3
5. Worst pruritus numerical rating scale ≥ 4

Exclusion criteria 3

1. Treatment with 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 1 week, prior to Day 1:• TCS of any potency • TCI • Topical phosphodiesterase type 4 (PDE4) inhibitors • Other topical immunosuppressive agents • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
3. Treatment with any of the following medications or therapies within 1 week, prior to Day 1: • Topical phosphodiesterase type 4 (PDE4) inhibitors • Other topical immunosuppressive agents • Combination agents including PDE4 inhibitors, or other immunosuppressive agents

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Whether or not a participant has a clear or almost clear skin at week 24 based on vIGA-AD.
2. Whether or not a participant’s eczema is at least 75% better at week 24 compared to the start of the study based on EASI.

Secondary endpoints 9

1. Whether or not a participant’s eczema has achieved certain improvement as compared to the start of the study based on EASI
2. Whether or not a participant has a clear or almost clear skin at week 16 based on vIGA-AD
3. Whether or not a participant has less skin itching at week 16 compared to the start of the study based on the participant’s daily scoring. Whether or not a participant has less skin itching at week 24 compared to the start of the study based on the participant’s daily scoring
4. Whether or not a participant’s eczema has achieved certain improvement at week 24 compared to the start of the study based on EASI
5. Whether or not a participant has less ezcema skin pain at week 24 compared to the start of the study based on participant's weekly scoring
6. Whether or not a participant has almost clear skin or almost clear skin with at most slight redness or clear skin at week 24
7. Whether or not a participant has an overall clear skin on the face at week 24.
8. Whether or not a participant has an overall clear skin on the hand at week 24.
9. A participant’s quality of life at week 24 compared to the start of the study while having eczema based on DLQI. DLQI measures how a participant feels about the quality of life because of skin diseases

Investigational products

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

Test 1

Placebo 1

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

11 EU/EEA countries · 57 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

Layperson summary Annex V

Documents 60 files

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

Application history

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