[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-877-240-9479

Email address

information.center@astrazeneca.com

Condition

Chronic Obstructive Pulmonary Disease

Treatment type

Interventional

Investigational product

Benralizumab

Phase

Phase 3

Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04053634

Study number

D3251C00014

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About the study

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy. Eligible patients must also have an elevated blood eosinophil count. The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. LAMA) background therapy for COPD throughout the year (52
  2. weeks) prior to enrollment. 1. ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily. 2. Total cumulative duration of not being on triple background therapy must not exceed 2 months. 3. Stable therapy/doses for the last 3 months prior to randomization. 8. Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in). 9. CAT total score ≥15 at Visit 1. 10. Negative pregnancy test for females of childbearing potential (
  3. WOCBP) at Visit 1. 11. Women of childbearing potential (
  4. WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP. Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).
Exclusion criteria
  1. years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care. 17. Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed). 18. History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable). 19. Scheduled major surgical procedure during the study. Minor elective procedures are allowed. 20. History of anaphylaxis to benralizumab or any other biologic therapy. 21. Receipt of blood products or immunoglobulins within 30 days prior to randomization. 22. Receipt of any marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. 23. Receipt of live attenuated vaccines 30 days prior to randomization. 24. Chronic use of immunosuppressive medication or expected need for chronic use during the study. 25. Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy. 26. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment. 27. Receipt of benralizumab within 12 months prior to enrollment. 28. Known history of allergy or reaction to any component of the IP formulation.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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