An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT02501629
• Date of registration: 14/07/2015
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
• Scientific title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
• Date of first enrolment: September 29, 2015
• Target sample size: 177
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02501629
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Czech Republic, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, South Africa, Spain, Ukraine, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The patient is male or female, 12 years of age and older, with a previous diagnosis of
asthma.

2. Written informed consent is obtained.

3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of
between 5 and 40 mg during the 3 months prior to screening.

4. The patient has a documented elevated blood eosinophils at screening or during the
previous 12 months.

5. The patient has required high dose ICS plus another asthma controller for at least 6
months prior to screening.

6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within
the previous 24 months.

- Other criteria may apply, please contact the investigator for more information.

Exclusion Criteria:

1. The patient has any clinically significant, uncontrolled medical condition that would
interfere with the study schedule or procedures and interpretation of efficacy results
or would compromise the patient's safety.

2. The patient has another confounding underlying lung disorder.

3. The patient has a known hypereosinophilic syndrome.

4. The patient has a history of any malignancy within 5 years of the screening visit,
except for treated and cured non-melanoma skin cancers.

5. The patient is pregnant or intends to become pregnant during the study or is
lactating.

6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.

7. The patient is a current smoker or has a smoking history =10 pack-years.

8. The patient is currently using any systemic immunosuppressive or immunomodulatory
biologic except maintenance OCS for the treatment of asthma.

9. The patient participated in a clinical study within 30 days or 5 half-lives of the
investigational drug before screening, whichever is longer.

10. The patient was previously exposed to benralizumab within 12 months of screening.

11. The patient was previously exposed to reslizumab.

12. The patient has a history of immunodeficiency disorder including human
immunodeficiency virus.

13. The patient has current suspected drug and/or alcohol abuse.

14. The patient has had an active helminthic parasitic infection or was treated for one
within 6 months of screening.

15. The patient has a history of allergic reactions or hypersensitivity to any component
of the study drug.

- Other criteria may apply, please contact the investigator for more information.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Elevated Blood Eosinophils

Oral Corticosteroid Dependence

Intervention(s)

Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication

Drug: Reslizumab

Drug: Placebo

Drug: Oral Corticosteroid (OCS)

Primary Outcome(s)

Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline [Time Frame: Baseline (Day 1), Weeks 20-24]

Secondary Outcome(s)

Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control [Time Frame: Weeks 20-24]

Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control [Time Frame: Baseline (Day 1), Weeks 20-24]

Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control [Time Frame: Baseline (Day 1), Weeks 20-24]

Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control [Time Frame: Weeks 20-24]

Annualized Rate of Clinical Asthma Exacerbations (CAEs) [Time Frame: Day 1 through Week 24]

Participants With Adverse Events [Time Frame: Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.]

Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses [Time Frame: Weeks 4, 8, 12, 24 or early withdrawal.]

Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures [Time Frame: Baseline (Day 1), Weeks 20-24]

Secondary ID(s)

C38072-AS-30027

2015-001580-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02501629