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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
Florida, Vicente Lopez
Country [26] 0 0
Argentina
State/province [26] 0 0
Mendoza
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Haskovo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Stara Zagora
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Chile
State/province [33] 0 0
Curico
Country [34] 0 0
Chile
State/province [34] 0 0
Santiago
Country [35] 0 0
Chile
State/province [35] 0 0
Talca
Country [36] 0 0
China
State/province [36] 0 0
Anhui
Country [37] 0 0
China
State/province [37] 0 0
Guangdong
Country [38] 0 0
China
State/province [38] 0 0
Hainan
Country [39] 0 0
China
State/province [39] 0 0
Hunan
Country [40] 0 0
China
State/province [40] 0 0
Jiangsu
Country [41] 0 0
China
State/province [41] 0 0
Jiangxi
Country [42] 0 0
China
State/province [42] 0 0
Shandong
Country [43] 0 0
China
State/province [43] 0 0
Shanghai
Country [44] 0 0
China
State/province [44] 0 0
Shanxi
Country [45] 0 0
China
State/province [45] 0 0
Zhejiang
Country [46] 0 0
Colombia
State/province [46] 0 0
Cundinamarca
Country [47] 0 0
Colombia
State/province [47] 0 0
Tolima
Country [48] 0 0
Czechia
State/province [48] 0 0
Brandys nad Labem - Stara Boleslav
Country [49] 0 0
Czechia
State/province [49] 0 0
Jindrichuv Hradec
Country [50] 0 0
Czechia
State/province [50] 0 0
Rokycany
Country [51] 0 0
Czechia
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Tabor
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Hong Kong
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Shatin, New Territories
Country [54] 0 0
Hungary
State/province [54] 0 0
Edeleny
Country [55] 0 0
Hungary
State/province [55] 0 0
Godollo
Country [56] 0 0
Hungary
State/province [56] 0 0
Puspokladany
Country [57] 0 0
Hungary
State/province [57] 0 0
Szazhalombatta
Country [58] 0 0
Japan
State/province [58] 0 0
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
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Kanagawa
Country [64] 0 0
Japan
State/province [64] 0 0
Kochi
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Tokyo
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Daegu
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
Mexico
State/province [69] 0 0
Chihuahua
Country [70] 0 0
Poland
State/province [70] 0 0
Bialystok
Country [71] 0 0
Poland
State/province [71] 0 0
Katowice
Country [72] 0 0
Poland
State/province [72] 0 0
Krakow
Country [73] 0 0
Poland
State/province [73] 0 0
Ostrowiec Swietokrzyski
Country [74] 0 0
Poland
State/province [74] 0 0
Poznan
Country [75] 0 0
Poland
State/province [75] 0 0
Wroclaw
Country [76] 0 0
Romania
State/province [76] 0 0
Bacau
Country [77] 0 0
Romania
State/province [77] 0 0
Cluj-Napoca
Country [78] 0 0
Romania
State/province [78] 0 0
Craiova
Country [79] 0 0
Romania
State/province [79] 0 0
Deva
Country [80] 0 0
Romania
State/province [80] 0 0
Suceava
Country [81] 0 0
Taiwan
State/province [81] 0 0
Kaohsiung
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taichung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Thailand
State/province [84] 0 0
Bangkok
Country [85] 0 0
Thailand
State/province [85] 0 0
Songkla
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Corby
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Manchester

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
[email protected]
Contact person for scientific queries

Data sharing statement


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