Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Benralizumab (MEDI-563) in Reducing Eosinophilia in Subjects With Hypereosinophilic Syndrome (HES)
Brief Summary: Background:

- Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES.

Objective:

- To test if benralizumab can safely decrease eosinophils in people with HES.

Eligibility:

- Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels.

Design:

* Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests.
* Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells.
* Phase 1: Participants will randomly receive either the study drug or placebo as an injection.
* They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects.
* They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection.
* Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.
* At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy.
* After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months.


Options:
A: Arm Label: CAT-354 1 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: CAT-354 1mg/kg | Arm Label: CAT-354 5 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: CAT-354 5 mg/kg | Arm Label: CAT-354 10mg/kg; Type: EXPERIMENTAL; Interventions: Biological: CAT-354 10mg/kg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: BIOLOGICAL; Name: CAT-354 1mg/kg; Assigned to Arm(s): CAT-354 1 mg/kg | Intervention Type: BIOLOGICAL; Name: CAT-354 5 mg/kg; Assigned to Arm(s): CAT-354 5 mg/kg | Intervention Type: BIOLOGICAL; Name: CAT-354 10mg/kg; Assigned to Arm(s): CAT-354 10mg/kg | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Drug; Type: ACTIVE_COMPARATOR; Interventions: Drug: benralizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: benralizumab; Assigned to Arm(s): Drug | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: MEDI-563 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: MEDI-563 | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo Comp. | Arm Label: 5; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: MEDI-563; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: MEDI-563; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Placebo Comp.; Assigned to Arm(s): 4 | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): 5
D: Arm Label: Mepolizumab 750mg; Type: ACTIVE_COMPARATOR; Interventions: Biological: Mepolizumab 750 | Arm Label: Mepolizumab 250mg; Type: ACTIVE_COMPARATOR; Interventions: Biological: Mepolizumab 250 | Arm Label: Mepolizumab 75mg; Type: ACTIVE_COMPARATOR; Interventions: Biological: Mepolizumab 75 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo saline | Intervention Type: BIOLOGICAL; Name: Mepolizumab 750; Assigned to Arm(s): Mepolizumab 750mg | Intervention Type: BIOLOGICAL; Name: Mepolizumab 250; Assigned to Arm(s): Mepolizumab 250mg | Intervention Type: BIOLOGICAL; Name: Mepolizumab 75; Assigned to Arm(s): Mepolizumab 75mg | Intervention Type: DRUG; Name: Placebo saline; Assigned to Arm(s): Placebo

Answer: B