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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
Date last updated
4/07/2025

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 prior to the screening visit, 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 = 35% and = 90% 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
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Kentucky
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Maryland
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Michigan
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Argentina
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Buenos Aires
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Argentina
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Distrito Federal
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Florida, Vicente Lopez
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Argentina
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Mendoza
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Bulgaria
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Haskovo
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Chile
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Curico
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Chile
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Santiago
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Chile
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Talca
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China
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Anhui
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China
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Guangdong
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China
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Hainan
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Zhejiang
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Colombia
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Cundinamarca
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Colombia
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Tolima
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Czechia
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Brandys nad Labem - Stara Boleslav
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Czechia
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Jindrichuv Hradec
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Czechia
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Rokycany
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Czechia
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Tabor
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin, New Territories
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Hungary
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Edeleny
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Hungary
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Godollo
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Puspokladany
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Kanagawa
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Kochi
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Chihuahua
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Poland
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Bialystok
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Poland
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Katowice
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Krakow
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Ostrowiec Swietokrzyski
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Poznan
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Wroclaw
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Romania
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Bacau
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Deva
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Romania
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Suceava
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Songkla
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United Kingdom
State/province [87] 0 0
Corby
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United Kingdom
State/province [88] 0 0
Glasgow
Country [89] 0 0
United Kingdom
State/province [89] 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