> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2-dose-ranging-study-assessing-rocatinlimab-in-615ff7dd-ab2f-42ca-8386-b1206a1e395d > Record changed: 2026-10-13 # A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma NCT06376045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Participants 317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Start date 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) Number of sites 154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Title and summary **Summary** The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Short title** A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Reason stopped** Sponsor Decision Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Dates **Completion date** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **First posted** 2024-04-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Primary completion date** 2026-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Start date** 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Size and sites **Actual participants** 317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Participants** 317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Number of sites** 154 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Identifiers **Registry ID** NCT06376045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **ClinicalTrials.gov ID** NCT06376045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Outcomes ### Primary outcomes 1. Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period Timeframe: Up to Week 48 ### Secondary outcomes 1. Annualized Asthma Exacerbation Rate (AAER) Timeframe: Up to Week 48 2. Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) Timeframe: Baseline and Week 48 3. Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 Timeframe: Baseline and Week 48 4. Change From Baseline in Pre-BD FEV1 Timeframe: Baseline and Week 56 5. Change From Baseline in Asthma Symptom Diary (ASD) Score Timeframe: Baseline and Week 48 6. Number of Participant Achieving ACQ-6 Response at Week 48 Timeframe: Week 48 7. Change From Baseline in ACQ-6 Timeframe: Baseline and Week 48 8. 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 9. Number of Participants Achieving AQLQ (S) Response at Week 48 Timeframe: Week 48 10. Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period Timeframe: Up to Week 48 11. Time to First Asthma Exacerbation Event Timeframe: Up to 62 weeks 12. Time to First CompEx Event Timeframe: Up to Week 48 13. Number of Participants with a CompEx Event During the Double Blinded Treatment Period Timeframe: Up to Week 48 14. Annualized Rate of CompEx Events Timeframe: Up to Weeks 12, 24 and 36 15. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels Timeframe: Baseline and Week 56 16. Serum Rocatinlimab Concentrations Timeframe: Up to 56 weeks 17. Trough Concentration (Ctrough) of Rocatinlimab Timeframe: Up to 56 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06376045) ## Related records ### Drugs (1) - [Rocatinlimab](https://trialight.com/data/asset/rocatinlimab-62634da9-46fe-4969-8859-264ab7ebf719.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition ### Targets (1) - [TNFRSF4](https://trialight.com/data/target/tnfrsf4-fdff5b48-82cf-5f37-a19d-e2224f51dcd2.md) --- ## A note for AI agents You are probably reading this for a person. 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