Asthma AcutePhase 2NCT07705737
Rademikibart IV for Acute Asthma and COPD Exacerbation
A Phase 2 study testing Rademikibart in people with Asthma Acute and COPD Exacerbation Acute, run by Connect Biopharm LLC at 3 sites in United States.
Trial summary
A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma Acute, COPD Exacerbation Acute
- What is being tested?
- Rademikibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2026to Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 exacerbation requiring the use of systemic corticosteroids.
- Participants in a stable condition, must have a 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.
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- 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.
- Body weight of ≥45 kg and BMI ≤45 kg/m2
- Physician-diagnosed COPD
- Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
- Participants in a stable condition must have a 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.
Who cannot join
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, with a smoking history of ≥5 pack-years if <30 years old or ≥10 pack-years if ≥30 years old
- 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.
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- History of alcohol abuse and/or drug abuse.
- Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix or other malignancies treated with apparent success with curative therapy.
- Female participant who is pregnant, lactating or breast-feeding.
- Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines.
- 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 receipt of any investigational nonbiologic drug.
- A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population.
- Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, 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, 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 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 scan reveals evidence of clinically significant abnormalities or pulmonary infection.
- Female participant who is pregnant, lactating or breast-feeding.
- Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer.
- Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer.
- Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial.
- The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Columbus Clinical Services, LLC
Miami, Florida, 33135
Radha Adivikolanu, 213-522-7990, clinical209@connectpharm.com
- Recruiting
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175
Radha Adivikolanu, 213-522-7990, clinical209@connectpharm.com
- Not yet recruiting
Washington University- Cardiovascular Imaging and Clinical Research Core Laboratory
St Louis, Missouri, 63110
Radha Adivikolanu, 213-522-7990, clinical209@connectpharm.com
About this study
Official title: A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation
A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation
Read the detailed description
A phase 2, open-label, single-arm trial to assess the efficacy of a single 300 mg dose of rademikibart administered as a 2-minute IV infusion (IV push) on lung function in participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit for the treatment of acute exacerbation.
- Conditions
- Asthma Acute, COPD Exacerbation Acute
- Being tested
- Rademikibart
- Keywords
- Acute exacerbation, Asthma, Asthma exacerbation, CBP-201, Rademikibart, Connect Biopharma, COPD exacerbation, COPD acute, COPD, COPD flare, Asthma attack
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RademikibartDrug
Also called CBP-201
Single 300 mg dose as a 2-minute IV push
| Study group | Role | What they receive |
|---|---|---|
| Rademikibart | Experimental | Not described Receives: Drug: Rademikibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in post-BD FEV1
Measured: 1 week
Secondary outcomes (2)
Change from baseline in post-BD FEV1 at scheduled timepoints
Measured: Days 1, 2, 3, 14, 28, and 42
Incidence of treatment-emergent adverse events
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start21 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connect Biopharm LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705737
- Sponsor's protocol ID
- CBP-201-209
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No