Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05651711




Registration number
NCT05651711
Ethics application status
Date submitted
7/12/2022
Date registered
15/12/2022
Date last updated
4/06/2024

Titles & IDs
Public title
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Scientific title
A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)
Secondary ID [1] 0 0
2022-501538-44
Secondary ID [2] 0 0
20210143
Universal Trial Number (UTN)
Trial acronym
ROCKET-Horizon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Other interventions - Placebo

Experimental: Rocatinlimab - Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Placebo Comparator: Placebo - Placebo Q4W for 24 weeks with a loading dose at Week 2.


Treatment: Drugs: Rocatinlimab
Rocatinlimab will be administered through a subcutaneous (SC) injection.

Other interventions: Placebo
The matching placebo will be administered through a SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a = 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
Achievement of = 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Achievement of EASI 75 at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Achievement of vIGA-AD 0/1 at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Achievement of = 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Achievement of = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score = 4
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Achievement of 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
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Timepoint [12] 0 0
Baseline and Week 16
Secondary outcome [13] 0 0
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Achievement of a = 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI = 4
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
Change From Baseline in DLQI Score at Week 24
Timepoint [15] 0 0
Baseline and Week 24
Secondary outcome [16] 0 0
Achievement of a = 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score = 4
Timepoint [16] 0 0
Baseline and Week 24
Secondary outcome [17] 0 0
Change from Baseline in POEM Score at Week 24
Timepoint [17] 0 0
Baseline and Week 24
Secondary outcome [18] 0 0
Achievement of = 4-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score = 4
Timepoint [18] 0 0
Baseline to Week 16
Secondary outcome [19] 0 0
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Timepoint [19] 0 0
Baseline to Week 24
Secondary outcome [20] 0 0
Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Timepoint [20] 0 0
Baseline and Week 16
Secondary outcome [21] 0 0
Achievement of = 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score = 3
Timepoint [21] 0 0
Baseline to Week 24
Secondary outcome [22] 0 0
Achievement of = 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score = 3
Timepoint [22] 0 0
Baseline to Week 16
Secondary outcome [23] 0 0
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Timepoint [23] 0 0
Baseline to Week 24
Secondary outcome [24] 0 0
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score = 8
Timepoint [24] 0 0
Baseline and Week 24
Secondary outcome [25] 0 0
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8
Timepoint [25] 0 0
Baseline and Week 24
Secondary outcome [26] 0 0
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Timepoint [26] 0 0
Baseline and Week 24
Secondary outcome [27] 0 0
Change From Baseline in HADS-depression Subscale Score at Week 24
Timepoint [27] 0 0
Baseline and Week 24
Secondary outcome [28] 0 0
Achievement of a = 8.7-point Reduction From Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score = 8.7
Timepoint [28] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
- Age = 18 years (or = legal adult age within the country if it is older than 18 years
at signing of informed consent) 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 or higher
potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for
whom topical treatments are otherwise medically inadvisable (eg, because of important
side effects or safety risks).

- EASI score =16

- vIGA-AD score =3

- =10% body surface area (BSA) of AD involvement

- Worst pruritus numerical rating scale = 4
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- Oral or topical 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 (PDE4) inhibitors

- Other topical immunosuppressive agents

- Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other
immunosuppressive agents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/08/2024
Actual
Sample size
Target
Accrual to date
Final
726
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Skin Health Institute - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Herstal
Country [29] 0 0
Belgium
State/province [29] 0 0
Maldegem
Country [30] 0 0
Brazil
State/province [30] 0 0
Paraná
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czechia
State/province [36] 0 0
Kutna Hora
Country [37] 0 0
Czechia
State/province [37] 0 0
Novy Jicin
Country [38] 0 0
Czechia
State/province [38] 0 0
Pardubice
Country [39] 0 0
Czechia
State/province [39] 0 0
Plzen
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 3
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 5
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 6
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha
Country [44] 0 0
Czechia
State/province [44] 0 0
Svitavy
Country [45] 0 0
Denmark
State/province [45] 0 0
Hellerup
Country [46] 0 0
Denmark
State/province [46] 0 0
Odense
Country [47] 0 0
Estonia
State/province [47] 0 0
Tallinn
Country [48] 0 0
Estonia
State/province [48] 0 0
Tartu
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Finland
State/province [50] 0 0
Oulu
Country [51] 0 0
Finland
State/province [51] 0 0
Tampere
Country [52] 0 0
Germany
State/province [52] 0 0
Bad Bentheim
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Halle (Saale)
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Kiel
Country [57] 0 0
Germany
State/province [57] 0 0
Leipzig
Country [58] 0 0
Germany
State/province [58] 0 0
Muenster
Country [59] 0 0
Germany
State/province [59] 0 0
Osnabrueck
Country [60] 0 0
Germany
State/province [60] 0 0
Remscheid
Country [61] 0 0
Germany
State/province [61] 0 0
Wuppertal
Country [62] 0 0
Japan
State/province [62] 0 0
Chiba
Country [63] 0 0
Japan
State/province [63] 0 0
Hyogo
Country [64] 0 0
Japan
State/province [64] 0 0
Kanagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Nagasaki
Country [66] 0 0
Japan
State/province [66] 0 0
Osaka
Country [67] 0 0
Japan
State/province [67] 0 0
Shizuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo
Country [69] 0 0
Japan
State/province [69] 0 0
Toyama
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Ansansi, Gyeonggido
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Bucheon-si, Gyeonggi-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Busan
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Daegu
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Gwangju
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Incheon
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seongnam-si, Gyeonggi-do
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Suwon-si, Gyeonggi-do
Country [79] 0 0
Mexico
State/province [79] 0 0
Michoacán
Country [80] 0 0
Mexico
State/province [80] 0 0
Chihuahua
Country [81] 0 0
Mexico
State/province [81] 0 0
Cuautitlán Izcalli
Country [82] 0 0
Poland
State/province [82] 0 0
Bialystok
Country [83] 0 0
Poland
State/province [83] 0 0
Chorzow
Country [84] 0 0
Poland
State/province [84] 0 0
Gdansk
Country [85] 0 0
Poland
State/province [85] 0 0
Krakow
Country [86] 0 0
Poland
State/province [86] 0 0
Lodz
Country [87] 0 0
Poland
State/province [87] 0 0
Lublin
Country [88] 0 0
Poland
State/province [88] 0 0
Poznan
Country [89] 0 0
Poland
State/province [89] 0 0
Warszawa
Country [90] 0 0
Portugal
State/province [90] 0 0
Almada
Country [91] 0 0
Portugal
State/province [91] 0 0
Coimbra
Country [92] 0 0
Portugal
State/province [92] 0 0
Lisboa
Country [93] 0 0
Portugal
State/province [93] 0 0
Porto
Country [94] 0 0
Romania
State/province [94] 0 0
Bucharest
Country [95] 0 0
South Africa
State/province [95] 0 0
Gauteng
Country [96] 0 0
South Africa
State/province [96] 0 0
Durban
Country [97] 0 0
Spain
State/province [97] 0 0
Andalucía
Country [98] 0 0
Spain
State/province [98] 0 0
Comunidad Valenciana
Country [99] 0 0
Spain
State/province [99] 0 0
Navarra
Country [100] 0 0
Spain
State/province [100] 0 0
Madrid
Country [101] 0 0
Spain
State/province [101] 0 0
Majadahonda
Country [102] 0 0
Sweden
State/province [102] 0 0
Stockholm
Country [103] 0 0
Turkey
State/province [103] 0 0
Ankara
Country [104] 0 0
Turkey
State/province [104] 0 0
Gaziantep
Country [105] 0 0
Turkey
State/province [105] 0 0
Istanbul
Country [106] 0 0
Turkey
State/province [106] 0 0
Izmir
Country [107] 0 0
Turkey
State/province [107] 0 0
Kayseri
Country [108] 0 0
Turkey
State/province [108] 0 0
Kocaeli
Country [109] 0 0
Turkey
State/province [109] 0 0
Sakarya
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Corby
Country [111] 0 0
United Kingdom
State/province [111] 0 0
London
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The co-primary objectives of the study are to:

- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).

- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using
Eczema Area and Severity Index (EASI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05651711
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05651711