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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Connect Biopharm LLC
Study ID
NCT06940141
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Asthma Acute

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rademikibart in prefilled syringe — COMBINATION_PRODUCT
    Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
  • Matching placebo in prefilled syringe — DRUG
    Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Study Details

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

Key Dates

Start date
Aug 8, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rademikibart
  • Placebo Comparator: Placebo

Primary Outcome Measure

Treatment failure rate within 28 days after randomization [ Time Frame: 28 days ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Leland Stanford Junior University, Stanford HospitalPalo AltoCalifornia94304
Radha Adivikolanu
Amicis Research CenterValenciaCalifornia91355
Radha Adivikolanu
Synergy HealthcareBradentonFlorida34209-
Columbus Clinical Services, LLCMiamiFlorida33215
Radha Adivikolanu
Pharmax Research of South Florida, Inc.MiamiFlorida33175
Radha Adivikolanu
Health Synergy Clinical Research, LLCWest Palm BeachFlorida33407
Radha Adivikolanu
Primeway Clinical Research GroupFayettevilleGeorgia30214
Radha Adivikolanu
Pivotal Research SolutionsStonecrestGeorgia30038
Radha Adivikolanu
University of IowaIowa CityIowa52242
Radha Adivikolanu
University of Kansas Medical CenterKansas CityKansas66160
Radha Adivikolanu
Allergy & Asthma Specialists, P.S.C.OwensboroKentucky42301
Radha Adivikolanu
Chesapeake Clinical Research, Inc.White MarshMaryland21162
Radha Adivikolanu
Washington University School of MedicineSt LouisMissouri63110
Radha Adivikolanu
The Ohio State University Wexner Medical CenterColumbusOhio43210
Radha Adivikolanu
Clinical Research of Rock HillRock HillSouth Carolina29732
Radha Adivikolanu
Inquest Clinical ResearchBaytownTexas77521
Radha Adivikolanu
Premier Pulmonary Critical Care and Sleep MedicineDenisonTexas75020
Radha Adivikolanu
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical TrialsMcAllenTexas78503
Radha Adivikolanu

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By research site
Leland Stanford Junior University, Stanford Hospital· Palo Alto, CAAmicis Research Center· Valencia, CASynergy Healthcare· Bradenton, FLColumbus Clinical Services, LLC· Miami, FLPharmax Research of South Florida, Inc.· Miami, FLHealth Synergy Clinical Research, LLC· West Palm Beach, FL

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