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

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 → 13 Jan 2025

Decision date (initial)

2023-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc.

External identifiers

EU CT number

2022-501540-15-00

WHO UTN

U1111-1282-5758

ClinicalTrials.gov

NCT05398445

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

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


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

Secondary objectives 8

1. To evaluate the efficacy of rocatinlimab compared with placebo at week 16, assessed using EASI
2. To evaluate the efficacy of rocatinlimab compared with placebo at week 16, assessed using vIGA-AD
3. To evaluate the efficacy of rocatinlimab compared with placebo at week 16 and week 24 on the patient reported outcome (PRO) measure of pruritus
4. To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using EASI
5. To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using vIGA-AD with an additional assessment of morphology
6. To evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the PRO measure of atopic dermatitis (AD) skin pain
7. To evaluate the efficacy of rocatinlimab compared with placebo on facial AD at week 24
8. To evaluate the efficacy of rocatinlimab compared with placebo on hand AD at week 24

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/NCT05398445) 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 or females aged ≥ 18 years or legal adult age within subject’s country, whichever is older, 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 or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
3. Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, defined as EASI score ≥ 16, vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) and ≥ 10% body surface area (BSA) of AD involvement. Additionally, patient-reported worst pruritus NRS >/= 4 based on a single-question item with 7-day recall is required at initial screening.

Exclusion criteria 3

1. Treatment with a biological immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition within 12 weeks or 5 half lives, whichever is longer, prior to day 1 prerandomization.
2. Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. -Systemic corticosteroids (inhaled corticosteroids, intra-articular steroid injection, eye, ear, or nasal drops containing corticosteroids are allowed, suppositories, or enemas containing corticosteroids are not allowed) -Systemic treatment with methotrexate, mycophenolate/mycophenolate mofetil, calcineurin inhibitors, thalidomide, or other non-biologic, non-targeted systemic immunosuppressants -Phototherapy -Oral or topical JAK inhibitors
3. Treatment with any of the following agents within 1 week before day 1 prerandomization: -Topical phosphodiesterase type 4 (PDE4) inhibitors -Other topical immunosuppressive agents -Combination topical agents including PDE4 inhibitors, or other topical immunosuppressive agents

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) with ≥ 2-point reduction from baseline (vIGA-AD 0/1) at week 24
2. Achieving ≥ 75% reduction from baseline in EASI score (EASI 75) at week 24

Secondary endpoints 8

1. Achieving EASI 75 at week 16
2. Achieving vIGA-AD 0/1 at week 16
3. Achieving from baseline in weekly average of daily worst pruritus numeric rating scale (NRS) score at week 16 in subjects with baseline weekly average of daily worst pruritus NRS score Achieving 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 ≥ 90% reduction from baseline in EASI score (EASI 90) at week 24
5. Acheiving 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 score.
6. Achieving Clear skin at week 24 for subjects with hand AD at baseline
7. Acheiving 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 score.
8. Achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA] 0/1) at week 24

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 13

Locations

12 EU/EEA countries · 70 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

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 43 files

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

Application history

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