ROCATINLIMAB for Asthma

Inclusion criteria

• {"criterion_text":"- Subjects must be between the ages of 18 and 75 inclusive or of legal age within the specific country( if different) at the time of signing the informed consent."}
• {"criterion_text":"- Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit."}
• {"criterion_text":"- Existing therapy with medium-dose to high-dose ICS (fluticasone propionate daily or equivalent ICS) with at least 1 additional controller medication (eg, LABA, 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. To be classified as being on medium-dose ICS, the subjects will be on a pre-determined total daily dose (sum of all ICS) of fluticasone propionate dry powder inhaler (DPI) equivalent. To be classified as being on high-dose ICS, the subjects will be on a pre-determined total daily dose of fluticasone propionate DPI equivalent. Classification of ICS doses (medium or high) will be based upon the GINA guidelines ICS classification table (GINA, 2022)."}

Exclusion criteria

• {"criterion_text":"- Subjects who experience an 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Active and non-virally suppressed hepatitis B infection at initial screening, defined as detectable hepatitis B DNA polymerase chain reaction (PCR) test in a subject with detectable hepatitis B Surface Antigen (HBsAg) and/or antibodies to hepatitis B core (anti HBc). Subjects with detectable HBsAg are required to be virally suppressed with an approved hepatitis B antiviral therapy during the study. For sites and subjects participating in the European Economic Area,"}
• {"criterion_text":"- Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA."}
• {"criterion_text":"- Any clinically important pulmonary disease other than asthma (eg, active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg Strauss syndrome, hypereosinophilic syndrome."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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; subjects with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Positive or indeterminate QuantiFERON GOLD from central laboratory at screening. If QuantiFERON GOLD from central laboratory is indeterminate it may be repeated once. If repeat test remains indeterminate or is positive the subject is excluded from participation. Exception: A positive or indeterminate QuantiFERON test is allowed if ALL of the following are present at day 1 pre-randomization: Documented history of a completed course of adequate prophylaxis (completed treatment for active or latent tuberculosis per local standard of care prior to start of investigational product.) No known exposure to a case of active TB after most recent prophylaxis. No evidence of active TB on chest radiograph obtained within 3 months prior to day 1 pre-randomization visit. Prior to enrollment, the participant must obtain approval from a TB specialist or an infectious diseases specialist."}
• {"criterion_text":"- Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma)."}
• {"criterion_text":"- History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Annualized asthma exacerbation rate (AAER) during the placebo-controlled treatment period (blinded treatment period). Exacerbation events are defined as worsening of asthma requiring the use of systemic corticosteroids for ≥ 3 days, emergency department visit resulting in requirement for systemic corticosteroids for ≥ 3 days or an inpatient hospitalization due to asthma","definition_or_measurement_approach":"AAER during the placebo-controlled (blinded) treatment period. Exacerbation events defined as worsening of asthma requiring systemic corticosteroids for ≥ 3 days, an ED visit requiring systemic corticosteroids for ≥ 3 days, or inpatient hospitalization due to asthma."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in Asthma Symptom diary (ASD) score at assessment timepoints","definition_or_measurement_approach":"Change from baseline in ASD score at scheduled assessment timepoints."}
• {"endpoint_text":"- Annualized rate of asthma exacerbation leading to hospitalization or emergency room visits during the blinded treatment period","definition_or_measurement_approach":"Annualized rate of exacerbations that lead to hospitalization or ED visits during blinded treatment period."}
• {"endpoint_text":"- Time to first asthma exacerbation event","definition_or_measurement_approach":"Time from randomization (or baseline) to first recorded asthma exacerbation event."}
• {"endpoint_text":"- Serum rocatinlimab concentrations at assessment timepoints","definition_or_measurement_approach":"Measurement of serum concentrations of rocatinlimab at specified assessment timepoints (pharmacokinetic sampling)."}

Methods

• Physician referral letters (Dr-to-Dr referral letter) for site referrals (country-specific versions present).
• Digital outreach (Outreach copy and outreach images) including study page (Study page_Eng, Study Page_Rou) to recruit potential participants online.
• Prescreener phone contact using a phone validation script (Phone Validation Script_Eng / RO) and prescreener materials to screen potential participants remotely.
• Calendly scheduling forms in multiple languages for booking screening or information sessions.
• Use of Antidote platform/registry (Antidote Privacy Policy documents included) for recruitment/participant matching.
• Pre-screening activities conducted by a third party (Reify Health) as part of recruitment workflow.
• Country-specific recruitment materials and patient-facing documents (materials available in English, Romanian, Bulgarian, Czech, Hungarian, Polish) to support local recruitment.

Hungary

Earliest CTIS Part Ii Submission Date

31-07-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

394

Number Of Sites

5

Number Of Participants

14

Czechia

Earliest CTIS Part Ii Submission Date

25-07-2024

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

397

Number Of Sites

4

Number Of Participants

30

Romania

Earliest CTIS Part Ii Submission Date

17-05-2024

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

468

Number Of Sites

5

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

01-09-2025

Processing Time Days

406

Number Of Sites

8

Number Of Participants

34

Bulgaria

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

394

Number Of Sites

5

Number Of Participants

17

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Emmes Biopharma Global s.r.o.

Responsibilities

Sponsor duty code 1

Name

Icon Clinical Research Limited

Responsibilities

Asthma Exacerbation adjudication

Name

Eresearchtechnology Inc.

Responsibilities

Sponsor duty code 7

Name

Suvoda LLC

Responsibilities

Sponsor duty code 3

Third parties

• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment for sites","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"Emmes Biopharma Global s.r.o.","duties_or_roles":"Sponsor duty code 1","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sponsor duty code 4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Eurofins Biomnis","duties_or_roles":"Sponsor duty code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duty code 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Lab Samples Storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sponsor duty code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Pre-screening activities","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Asthma Exacerbation adjudication","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duty code 7","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"Sponsor duty code 4","organisation_type":"Pharmaceutical company"}