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

JRCT ID: jRCT2051240043

Registered date:27/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 12/07/2024
• Target sample size: 428
• Countries of recruitment: Argentina,Japan,Australia,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Czech Republic,Japan,Hong Kong,Japan,Hungary,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Romania,Japan,South Korea,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period

Secondary Outcome

1. Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
2. Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
3. Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48
4. Change From Baseline in Pre-BD FEV1
5. Change From Baseline in Asthma Symptom Diary (ASD) Score
6. Number of Participant Achieving ACQ-6 Response at Week 48
7. Change From Baseline in ACQ-6
8. Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score
9.Number of Participants Achieving AQLQ (S) Response at Week 48
10. Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period
11. Time to First Asthma Exacerbation Event
12. Time to First CompEx Event
13. Number of Participants with a CompEx Event During the Double Blinded Treatment Period
14. Annualized Rate of CompEx Events
15. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
16. Serum Rocatinlimab Concentrations
17. Trough Concentration (Ctrough) of Rocatinlimab
18. Number of Participants with Treatment-emergent Adverse Events
19. Number of Participants with Serious Adverse Events
20. Number of Participants with Anti-rocatinlimab Antibody Formation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Participants must be between the ages of 18 and 75.
2. Asthma diagnosed by a physician for >= 12 months prior to the screening visit.
3. Existing therapy with medium to high doses of inhaled corticosteroids (ICS) (defined as > 250 microgram 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.
4. 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 microgram fluticasone propionate or equivalent ICS).
5. Morning pre-BD FEV1 >= 40% and <= 80% of predicted normal at the screening visit and day 1 pre-randomization visits.
6. ACQ-6 score >= 1.5 at the day 1 pre randomization visit.

Exclude criteria

1. 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.
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; participants 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.
7. Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
8. History of major immunologic 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,
12. Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

Related Information

• Primary Sponsor: Jain Neal
• Secondary ID(s): NCT06376045