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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06940154




Registration number
Help: Registration number
NCT06940154
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
3/04/2025
Date registered
Help: Date registered
23/04/2025
Date last updated
Help: Date last updated
16/09/2026

Titles & IDs
Public title
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Scientific title
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
Additional trial identifiers [1] 0 0
CBP-201-207
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
COPD Acute Exacerbation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Other interventions - Rademikibart in prefilled syringe
Treatment: Drugs - Matching placebo in prefilled syringe

Experimental: Rademikibart -

Placebo comparator: Placebo -


Other interventions: Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

Treatment: Drugs: Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Treatment failure rate
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1
Timepoint [1] 0 0
Week 1
Secondary outcome [2] 0 0
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Mean CFB in EXACT-PRO score
Timepoint [4] 0 0
Week 1, Week 2, and Week 4
Secondary outcome [5] 0 0
Absolute CFB in post-BD FEV1 at Day 3 and Week 4
Timepoint [5] 0 0
Day 3, Week 1, and Week 4
Secondary outcome [6] 0 0
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Timepoint [6] 0 0
56 days
Secondary outcome [7] 0 0
Incidence of unanticipated adverse device effects (UADEs)
Timepoint [7] 0 0
56 days
Secondary outcome [8] 0 0
Incidence of injection site reactions
Timepoint [8] 0 0
56 days

Eligibility
Key inclusion criteria
* Physician-diagnosed COPD with duration of =12 months.
* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
* Participants in a stable condition must have a documented historical peripheral blood eosinophil count of =250 cells/µL and/or FeNO = 25 ppb.
* Current or former smoker with a history of smoking of =10 pack-years.
* Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
* Peripheral blood eosinophil count of =300 cells/µL as part of the assessment of the index acute COPD exacerbation.
* Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
* Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
* Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
* Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
* Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit.
* 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.
* Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day.
* Participants on long-term macrolide.
* Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening.
* A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
* Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary ß-hCG test prior to randomization.
* Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
* Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
* Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
* Treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.

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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2026
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 0 0
Bendigo Health - Bendigo
Recruitment hospital [7] 0 0
Institute for Respiratory Health - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
3550 - Bendigo
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe Province
Country [18] 0 0
Argentina
State/province [18] 0 0
Tucumán Province
Country [19] 0 0
Argentina
State/province [19] 0 0
Santa Fe
Country [20] 0 0
Georgia
State/province [20] 0 0
Tbilisi
Country [21] 0 0
Serbia
State/province [21] 0 0
Belgrade
Country [22] 0 0
Serbia
State/province [22] 0 0
Kamenitz
Country [23] 0 0
Serbia
State/province [23] 0 0
Kragujevac
Country [24] 0 0
Serbia
State/province [24] 0 0
Niš
Country [25] 0 0
Serbia
State/province [25] 0 0
Užice
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Greater Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Birmingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Connect Biopharm LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Radha Adivikolanu
Address 0 0
Country 0 0
Phone 0 0
213-522-7990
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06940154