Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) in Combination with Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Moderate-to-severe AD (ROCKET-SHUTTLE)

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

11 May 2023 → 17 Jun 2025

Decision date (initial)

2023-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2022-501585-22-00

WHO UTN

U1111-1283-6276

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

​To evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at week 24, assessed using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD TM) 


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

Secondary objectives 8

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

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/NCT05724199) 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. Prior to informed consent, history of inadequate response to TCS of medium or higher potency (refer to Table 11 4) (with or without TCI as appropriate)
2. ​Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, defined as EASI score ≥ 16, vIGA-AD score ≥ 3 and ≥ 10% body surface area (BSA) of AD involvement.  Additionally, patient reported worst pruritus numeric rating scale (NRS) ³ 4 at initial screening.​
3. ​​Males or females aged ≥ 18 years 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 the date of informed consent.

Exclusion criteria 3

1. Treatment with a biologic immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition (eg, dupilumab, tralokinumab, lebrikizumab, other interleukin-inhibitors, anti-immunoglobulin E [IgE], tumor necrosis factor [TNF] inhibitors) within 12 weeks or 5 halflives, 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, calcineurin inhibitors, or other non-biological, 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: TCS of any potency TCI Topical PDE4 inhibitors Other topical immunosuppressive agents Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

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

Secondary endpoints 9

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
4. 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
5. Achieving ≥ 90% reduction from baseline in EASI score (EASI 90) at week 24
6. Change from baseline in weekly average of daily AD skin pain NRS score at week 24
7. Achieving vIGA-AD response with presence of only barely perceptible erythema or vIGA-AD 0 response at week 24
8. Achieving a Facial AD Severity Score of clear at week 24 for subjects with facial AD at baseline
9. Achieving a Hand AD Severity Score of clear at week 24 for subjects with hand AD at baseline

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

14 EU/EEA countries · 90 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 49 files

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

Application history

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