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The trial is taking place at:
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Allergy and Asthma Clinical Research | Walnut Creek, CA

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A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

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Amgen

Status and phase

Enrolling
Phase 2

Conditions

Asthma

Treatments

Drug: Placebo
Drug: Rocatinlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06376045
20220093

Details and patient eligibility

About

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Enrollment

428 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller (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 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

428 participants in 4 patient groups, including a placebo group

Treatment Arm A: Placebo
Placebo Comparator group
Description:
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
Treatment:
Drug: Placebo
Treatment Arm B: Dose 1 Rocatinlimab
Experimental group
Description:
Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.
Treatment:
Drug: Rocatinlimab
Treatment Arm C: Dose 2 Rocatinlimab
Experimental group
Description:
Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.
Treatment:
Drug: Rocatinlimab
Treatment Arm D: Dose 3 Rocatinlimab
Experimental group
Description:
Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
Treatment:
Drug: Rocatinlimab

Trial contacts and locations

38

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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