A Phase 2, Double-blind, Placebo-controlled, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

16 Sep 2024 → ongoing

Decision date (initial)

2024-08-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc

External identifiers

EU CT number

2023-508039-29-00

WHO UTN

U1111-1301-7345

ClinicalTrials.gov

NCT06376045

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

To describe the efficacy of rocatinlimab in reducing exacerbations

Secondary objectives 7

1. To describe the efficacy of rocatinlimab in improving measures of lung function
2. To describe the efficacy of rocatinlimab on composite exacerbation outcomes
3. To describe the efficacy of rocatinlimab at various time points on measures of lung function
4. To describe the efficacy of rocatinlimab at various time points on improving patient-reported measures of symptoms
5. To describe the efficacy of rocatinlimab at various time points on improving health-related quality of life
6. To describe the efficacy of rocatinlimab on other parameters of asthma exacerbations
7. To describe the safety of rocatinlimab

Conditions and MedDRA coding

Moderate-to-severe Asthma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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.
2. Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.
3. 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 12

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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).
8. History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.
9. 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.
10. 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
11. 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,
12. Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 4

1. Change from baseline in Asthma Symptom diary (ASD) score at assessment timepoints
2. Annualized rate of asthma exacerbation leading to hospitalization or emergency room visits during the blinded treatment period
3. Time to first asthma exacerbation event
4. Serum rocatinlimab concentrations at assessment timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 11

Locations

5 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 82 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications