Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)

Purpose

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Condition

  • Asthma Acute

Eligibility

Eligible Ages
Between 12 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Physician-diagnosed asthma with duration of ≥12 months. - Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication. - Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids. - For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. - Current acute asthma exacerbation requiring an urgent healthcare visit for treatment. - Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation. - Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation. - FEV1 ≥30% predicted.

Exclusion Criteria

  • Regular use of immunosuppressive medication. - Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. - Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years - COPD and other clinically significant pulmonary disease other than asthma. - Known or suspected history of immunosuppression. - History of known immunodeficiency disorder or hepatitis B or C. - History of alcohol abuse and/or drug abuse. - Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy. - Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization. - Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate). - Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases. - Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial. - Participants that have been recently treated with bronchial thermoplasty. - Recent treatment with OCS and/or hospitalization for an exacerbation of asthma. - Recent receipt of any investigational nonbiologic drug. - A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population. The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rademikibart
  • Combination Product: Rademikibart in prefilled syringe
    Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
    Other names:
    • CBP-201
Placebo Comparator
Placebo
  • Drug: Matching placebo in prefilled syringe
    Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Recruiting Locations

Leland Stanford Junior University, Stanford Hospital
Palo Alto, California 94304
Contact:
Radha Adivikolanu

Amicis Research Center
Valencia, California 91355
Contact:
Radha Adivikolanu

Pharmax Research of South Florida, Inc.
Miami, Florida 33175
Contact:
Radha Adivikolanu

Columbus Clinical Services, LLC
Miami, Florida 33215
Contact:
Radha Adivikolanu

Health Synergy Clinical Research, LLC
West Palm Beach, Florida 33407
Contact:
Radha Adivikolanu

Primeway Clinical Research Group
Fayetteville, Georgia 30214
Contact:
Radha Adivikolanu

Pivotal Research Solutions
Stonecrest, Georgia 30038
Contact:
Radha Adivikolanu

University of Iowa
Iowa City, Iowa 52242
Contact:
Radha Adivikolanu

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Radha Adivikolanu

Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky 42301
Contact:
Radha Adivikolanu

Chesapeake Clinical Research, Inc.
White Marsh, Maryland 21162
Contact:
Radha Adivikolanu

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Radha Adivikolanu

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Contact:
Radha Adivikolanu

Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
Contact:
Radha Adivikolanu

Inquest Clinical Research
Baytown, Texas 77521
Contact:
Radha Adivikolanu

Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas 75020
Contact:
Radha Adivikolanu

DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas 78503
Contact:
Radha Adivikolanu

More Details

Status
Recruiting
Sponsor
Connect Biopharm LLC

Study Contact

Radha Adivikolanu
213-522-7990
clinical206@connectpharm.com

Detailed Description

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.