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
- Are there results?
- Not yet: the study is under way
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, 2 recruiting
- Active, not recruiting
Columbus Clinical Services, LLC
Miami, Florida, 33135
- Recruiting
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175
Radha Adivikolanu, 213-522-7990, clinical209@connectpharm.com
- 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
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07705737
- Acronym / sponsor ID
- CBP-201-209
- Conditions
- Asthma Acute, COPD Exacerbation Acute
- Keywords
- Acute exacerbation, Asthma, Asthma exacerbation, CBP-201, Rademikibart, Connect Biopharma, COPD exacerbation, COPD acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Connect Biopharm LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rademikibart | Experimental | Drug: Rademikibart |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RademikibartAlso: CBP-201Single 300 mg dose as a 2-minute IV push | Drug | Rademikibart |
Primary outcome
Change from baseline in post-BD FEV1
Time frame: 1 week
2 secondary outcomes
Change from baseline in post-BD FEV1 at scheduled timepoints
Time frame: Days 1, 2, 3, 14, 28, and 42
Incidence of treatment-emergent adverse events
Time frame: 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radha Adivikolanu (213-522-7990, clinical209@connectpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in post-BD FEV1 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.