NCT07705737

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
5mo left

Started Jul 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Asthma AcuteCOPD Exacerbation Acute

Keywords

Acute exacerbationAsthmaAsthma exacerbationCBP-201RademikibartConnect BiopharmaCOPD exacerbationCOPD acuteCOPDCOPD flareAsthma attack

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in post-BD FEV1

    1 week

Secondary Outcomes (2)

  • 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

Study Arms (1)

Rademikibart

EXPERIMENTAL
Drug: Rademikibart

Interventions

RademikibartDRUG

Single 300 mg dose as a 2-minute IV push

Also known as: CBP-201
Rademikibart

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbus Clinical Services, LLC

Miami, Florida, 33135, United States

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Radha Adivikolanu

CONTACT

213-522-7990clinical209@connectpharm.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

US(1)