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Rademikibart in prefilled syringe

Phase 2

Asthma Acute | Small molecule | Respiratory |Connect Biopharma Holdings Limited|Last Updated: Aug 6, 2026

Target and mechanism

ModalitySmall molecule

Also known as Rademikibart

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Rademikibart in prefilled syringe · 3 trials · 3 indications

Phase 2 3
NCT07705737Rademikibart IV for Acute Asthma and COPD ExacerbationAsthma Acute
NOT YET_RECRUITING40 Analytics
NCT06940154Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)COPD Acute Exacerbation
ACTIVE NOT_RECRUITING160 Analytics
NCT06940141Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)Asthma Acute
ACTIVE NOT_RECRUITING160 Analytics
PHASE2NOT YET_RECRUITING
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma AcuteUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
COPD Acute ExacerbationUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Asthma AcuteUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in post-BD FEV1
1 week
Treatment failure rate
28 days

Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.

Treatment failure rate within 28 days after randomization
28 days

Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.

Secondary Endpoints

Change from baseline in post-BD FEV1 at scheduled timepoints
Days 1, 2, 3, 14, 28, and 42
Incidence of treatment-emergent adverse events
42 days
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Week 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RademikibartEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RademikibartDRUGSingle 300 mg dose as a 2-minute IV push
Rademikibart in prefilled syringeCOMBINATION_PRODUCTParticipants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Matching placebo in prefilled syringeDRUGParticipants receive 4mL of placebo matched to rademikibart administered subcutaneously.
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria - Asthma cohort * Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a. * Physician-diagnosed asthma * 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 exa...

Countries:United StatesArgentinaAustraliaGeorgiaSerbiaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 6, 2026NCT06940141primaryCompletionDate: changed
LOWAug 6, 2026NCT06940141primaryCompletionDate: changed

Frequently asked questions about Rademikibart in prefilled syringe

What is Rademikibart in prefilled syringe used for?

Rademikibart in prefilled syringe is an investigational small molecule being developed for acute exacerbations of asthma and COPD. It is being studied as an add-on treatment in Phase 2 clinical trials for these respiratory conditions.

Who makes Rademikibart in prefilled syringe?

Rademikibart in prefilled syringe is being developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTB.

What phase is Rademikibart in prefilled syringe in?

Rademikibart in prefilled syringe is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are active but not recruiting, and one is not yet recruiting.

What clinical trials is Rademikibart in prefilled syringe in?

Rademikibart in prefilled syringe is being studied in three Phase 2 trials: NCT06940141 for acute asthma exacerbation, NCT06940154 for acute COPD exacerbation, and NCT07705737 for acute asthma and COPD exacerbation. The trials are randomized, double-blind, and placebo-controlled.

Is Rademikibart in prefilled syringe the same as Rademikibart?

Yes, Rademikibart in prefilled syringe is the same drug as Rademikibart. The prefilled syringe formulation is one delivery method being studied, while other trials use intravenous administration.