A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
- Summary
- The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
- Short title
- A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
- Official 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Reason stopped
- Sponsor Decision
- Completion date
- 2026-06-23
- First posted
- 2024-04-19
- Registry last updated
- 2026-08-11
- Primary completion date
- 2026-05-14
- Start date
- 2024-05-24
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06376045
- ClinicalTrials.gov ID
- NCT06376045
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
Timeframe: Up to Week 48
Annualized Asthma Exacerbation Rate (AAER)
Timeframe: Up to Week 48
Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Baseline and Week 48
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
Timeframe: Baseline and Week 48
Change From Baseline in Pre-BD FEV1
Timeframe: Baseline and Week 56
Change From Baseline in Asthma Symptom Diary (ASD) Score
Timeframe: Baseline and Week 48
Number of Participant Achieving ACQ-6 Response at Week 48
Timeframe: Week 48
Change From Baseline in ACQ-6
Timeframe: Baseline and Week 48
Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score
Timeframe: Baseline, Weeks 12, 24, 36 and 48
Number of Participants Achieving AQLQ (S) Response at Week 48
Timeframe: Week 48
Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
Timeframe: Up to Week 48
Time to First Asthma Exacerbation Event
Timeframe: Up to 62 weeks
Time to First CompEx Event
Timeframe: Up to Week 48
Number of Participants with a CompEx Event During the Double Blinded Treatment Period
Timeframe: Up to Week 48
Annualized Rate of CompEx Events
Timeframe: Up to Weeks 12, 24 and 36
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Timeframe: Baseline and Week 56
Serum Rocatinlimab Concentrations
Timeframe: Up to 56 weeks
Trough Concentration (Ctrough) of Rocatinlimab
Timeframe: Up to 56 weeks
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Kern Research IncBakersfield, United States
- Orso Health IncLa Jolla, United States
- Imax Clinical TrialsLa Palma, United States
- Antelope Valley Clinical TrialsLancaster, United States
- Downtown Los Angeles Research Center, IncLos Angeles, United States
- NewportNativeMD, IncNewport Beach, United States
- University of California IrvineOrange, United States
- Apex Clinical ResearchSan Diego, United States
- Allergy and Asthma Clinical ResearchWalnut Creek, United States
- Allianz Research Institute WestminsterWestminster, United States
- St Francis Medical InstituteClearwater, United States
- BioMed Research InstituteMiami, United States
- Bright Research Center LLCMiami, United States
- Infinity Life Research GroupTamarac, United States
- Clinical Research Trials of Florida IncTampa, United States
- AllerVie Clinical Research- ColumbusColumbus, United States
- Treasure Valley Medical ResearchBoise, United States
- Sneeze, Wheeze, and Itch Associates, LLCNormal, United States
- Family Allergy and Asthma Research InstituteLouisville, United States
- Chesapeake Clinical Research IncWhite Marsh, United States
- Henry Ford Health SystemDetroit, United States
- Respiratory Medicine Research Institute of Michigan, plcYpsilanti, United States
- Midwest Chest Consultants, PCSaint Charles, United States
- Montana Medical ResearchMissoula, United States
- Somnos Clinical ResearchLincoln, United States
And 129 more, listed on the interactive page.
- Related resource (www.amgentrials.com)
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Asthma Primary condition