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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06376045




Registration number
NCT06376045
Ethics application status
Date submitted
17/04/2024
Date registered
19/04/2024

Titles & IDs
Public title
A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma
Secondary ID [1] 0 0
20220093
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

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

Placebo comparator: Treatment Arm A: Placebo - Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.

Experimental: Treatment Arm B: Dose 1 Rocatinlimab - Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.

Experimental: Treatment Arm C: Dose 2 Rocatinlimab - Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.

Experimental: Treatment Arm D: Dose 3 Rocatinlimab - Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.


Treatment: Drugs: Rocatinlimab
Rocatinlimab will be administered by SC injection.

Treatment: Drugs: Placebo
Placebo will be administered by SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period
Timepoint [1] 0 0
Up to approximately two years
Secondary outcome [1] 0 0
Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [1] 0 0
Up to approximately two years
Secondary outcome [2] 0 0
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
Timepoint [2] 0 0
Up to approximately two years
Secondary outcome [3] 0 0
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
Timepoint [3] 0 0
Up to approximately two years
Secondary outcome [4] 0 0
Change From Baseline in Pre-BD FEV1
Timepoint [4] 0 0
Up to approximately two years
Secondary outcome [5] 0 0
Change From Baseline in Asthma Symptom Diary (ASD) Score
Timepoint [5] 0 0
Up to approximately two years
Secondary outcome [6] 0 0
Number of Participant Achieving ACQ-6 Response at Week 48
Timepoint [6] 0 0
Up to approximately two years
Secondary outcome [7] 0 0
Change From Baseline in ACQ-6
Timepoint [7] 0 0
Up to approximately two years
Secondary outcome [8] 0 0
Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score
Timepoint [8] 0 0
Up to approximately two years
Secondary outcome [9] 0 0
Number of Participants Achieving AQLQ (S) Response at Week 48
Timepoint [9] 0 0
Up to approximately two years
Secondary outcome [10] 0 0
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
Timepoint [10] 0 0
Up to approximately two years
Secondary outcome [11] 0 0
Time to First Asthma Exacerbation Event
Timepoint [11] 0 0
Up to approximately two years
Secondary outcome [12] 0 0
Time to First CompEx Event
Timepoint [12] 0 0
Up to approximately two years
Secondary outcome [13] 0 0
Number of Participants with a CompEx Event During the Double Blinded Treatment Period
Timepoint [13] 0 0
Up to approximately two years
Secondary outcome [14] 0 0
Annualized Rate of CompEx Events
Timepoint [14] 0 0
Up to approximately two years
Secondary outcome [15] 0 0
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Timepoint [15] 0 0
Up to approximately two years
Secondary outcome [16] 0 0
Serum Rocatinlimab Concentrations
Timepoint [16] 0 0
Up to approximately two years
Secondary outcome [17] 0 0
Trough Concentration (Ctrough) of Rocatinlimab
Timepoint [17] 0 0
Up to approximately two years
Secondary outcome [18] 0 0
Number of Participants with Treatment-emergent Adverse Events
Timepoint [18] 0 0
Up to approximately two years
Secondary outcome [19] 0 0
Number of Participants with Serious Adverse Events
Timepoint [19] 0 0
Up to approximately two years
Secondary outcome [20] 0 0
Number of Participants with Anti-rocatinlimab Antibody Formation
Timepoint [20] 0 0
Up to approximately two years

Eligibility
Key inclusion criteria
* Participants must be between the ages of 18 and 75.
* Asthma diagnosed by a physician for = 12 months prior to the screening visit.
* Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist [LTRA], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.
* Documented history of = 1 asthma exacerbation in the past year, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 µg fluticasone propionate or equivalent ICS).
* Morning pre-BD FEV1 = 40% and = 80% of predicted normal at the screening visit and day 1 pre-randomization visits.
* ACQ-6 score = 1.5 at the day 1 pre randomization visit.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
* Any clinically important pulmonary disease other than asthma.
* Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of > 10 pack-years.
* Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
* Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
* Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
* History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
* Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
* Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
* Active and non-virally suppressed hepatitis B infection at initial screening,
* Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/10/2026
Actual
Sample size
Target
428
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3141 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucuman
Country [25] 0 0
Argentina
State/province [25] 0 0
Mendoza
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Haskovo
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sofia
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Stara Zagora
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Chile
State/province [32] 0 0
Curico
Country [33] 0 0
Chile
State/province [33] 0 0
Santiago
Country [34] 0 0
Chile
State/province [34] 0 0
Talca
Country [35] 0 0
China
State/province [35] 0 0
Guangdong
Country [36] 0 0
China
State/province [36] 0 0
Hunan
Country [37] 0 0
China
State/province [37] 0 0
Jiangsu
Country [38] 0 0
China
State/province [38] 0 0
Jiangxi
Country [39] 0 0
China
State/province [39] 0 0
Shandong
Country [40] 0 0
China
State/province [40] 0 0
Zhejiang
Country [41] 0 0
Czechia
State/province [41] 0 0
Brandys nad Labem - Stara Boleslav
Country [42] 0 0
Czechia
State/province [42] 0 0
Jindrichuv Hradec
Country [43] 0 0
Czechia
State/province [43] 0 0
Rokycany
Country [44] 0 0
Czechia
State/province [44] 0 0
Tabor
Country [45] 0 0
Hong Kong
State/province [45] 0 0
Hong Kong
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Hong Kong
State/province [46] 0 0
Shatin, New Territories
Country [47] 0 0
Hungary
State/province [47] 0 0
Edeleny
Country [48] 0 0
Hungary
State/province [48] 0 0
Godollo
Country [49] 0 0
Hungary
State/province [49] 0 0
Puspokladany
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Hungary
State/province [50] 0 0
Szazhalombatta
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Japan
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Fukui
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Japan
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Gifu
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Japan
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Hokkaido
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
State/province [56] 0 0
Kanagawa
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Japan
State/province [57] 0 0
Kochi
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
Country [59] 0 0
Japan
State/province [59] 0 0
Tokyo
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Daegu
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Poland
State/province [62] 0 0
Bialystok
Country [63] 0 0
Poland
State/province [63] 0 0
Katowice
Country [64] 0 0
Poland
State/province [64] 0 0
Krakow
Country [65] 0 0
Poland
State/province [65] 0 0
Ostrowiec Swietokrzyski
Country [66] 0 0
Poland
State/province [66] 0 0
Poznan
Country [67] 0 0
Poland
State/province [67] 0 0
Wroclaw
Country [68] 0 0
Romania
State/province [68] 0 0
Bacau
Country [69] 0 0
Romania
State/province [69] 0 0
Cluj-Napoca
Country [70] 0 0
Romania
State/province [70] 0 0
Craiova
Country [71] 0 0
Romania
State/province [71] 0 0
Deva
Country [72] 0 0
Romania
State/province [72] 0 0
Suceava
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung
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Taiwan
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Taichung
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taipei
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Corby
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06376045