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Moderate to Severe Persistent AsthmaPhase 2NCT04773678

Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

A Phase 2 study testing CBP-201 in people with Moderate to Severe Persistent Asthma, run by Connect Biopharm LLC at 76 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate to Severe Persistent Asthma
What is being tested?
CBP-201
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
322 participants
Where
76 sitesin 5 countries
Study dates
11 May 2021to 28 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female patient aged 18 to 75 years with a physician diagnosis of asthma for a minimum of 12 months, based on the Global Initiative for Asthma (GINA) 2020 Guidelines.
  • Patient is currently receiving treatment with medium to high dose inhaled corticosteroids (ICS) in combination with at least 1 additional reliever/controller for at least 90 days prior to the Screening Visit with a stable dose of ICS at least 28 days prior to the Screening Visit.
  • Note:
  • Patients receiving ICS equivalent to ≥ 226 μg fluticasone propionate twice daily or equipotent ICS daily dosage of a maximum of 2000 μg/day fluticasone propionate (or equivalent) in combination with a second reliever/controller (eg, long-acting ß agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], theophylline) are eligible.
  • Patients receiving fluticasone furoate/vilanterol with fluticasone furoate ≥ 200 μg once daily are eligible.
  • Patients receiving budesonide/formoterol with budesonide ≥ 640 μg/day are eligible.
Show all 23Show fewer
  • Patients requiring a third reliever/controller for their asthma are eligible.
  • Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤ 10 mg/day prednisone or equivalent OCS in addition to ICS are eligible; OCS total daily dose must have been stable at least 28 days prior to Screening.
  • Prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1) must be 40 to 85% of predicted normal at Screening and predose Baseline.
  • Patients must have ≥ 12% reversibility (and ≥ 200 mL difference) in FEV1 within 15 to 30 minutes after the administration of up to 4 puffs of albuterol/salbutamol at Screening.
  • Blood eosinophil count ≥ 300 cells/μL at Screening.
  • Asthma Control Questionnaire, 6-question (ACQ-6) score ≥ 1.5 at Screening and Baseline.
  • Patient has experienced an asthma exacerbation at least once in the past 12 months, defined here as:
  • Use of physician prescribed systemic corticosteroid [oral or parenteral], or
  • Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
  • Hospitalization or emergency medical care due to asthma.
  • Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques during the Screening Period in the opinion of the Investigator.
  • Patient demonstrates at least 70% compliance with usual asthma controller use during Run-in Period, based on their patient diary in the 7 days prior to dosing.
  • Patient demonstrates at least 70% compliance with recording of symptom scores in the patient-reported outcomes (PRO) diary completion during Run-in Period and in their handheld pulmonary function device in the 7 days prior to dosing.
  • Patient is able to understand and willing to sign the informed consent form (ICF).
  • Patient is willing and able to comply with clinic visit schedule and study-related procedures, in the opinion of the Investigator.
  • Male patients and their female partners of child-bearing potential agree to practice adequate and effective forms of contraception through the duration of the study from first dose to 8 weeks after the last dose of study drug.
  • Female patients of childbearing potential who are sexually active with a non-sterilized male partner agree to practice adequate and effective forms of contraception from first dose to 8 weeks after last dose of study drug.

Who cannot join

  • -
  • A patient who meets any of the following criteria will be ineligible to participate in this study:
  • Patient has a current diagnosis of a respiratory disorder other than asthma (eg, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis) or other disease associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
  • Patient has an acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 30 days prior to the date of informed consent or during the Screening/Run-in Period. Note: Patients must be symptom-free for at least 30 days.
  • Patient experiences ana asthma exacerbation at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit. Exacerbation is defined as:
  • Use of physician prescribed systemic corticosteroid [oral or parenteral], or
Show all 35Show fewer
  • Asthma requiring treatment increase of approximately 4 times the baseline dose of ICS, or
  • Hospitalization or emergency medical care due to asthma.
  • Current smoker or former smoker with a smoking history of > 10 pack-years. Note: This includes tobacco, marijuana, and vaping products.
  • Patient is undergoing or planning to undergo any elective surgery during the study requiring general anesthesia.
  • Patient has received treatment with any marketed (eg, omalizumab, benralizumab, mepolizumab, reslizumab, dupilumab) or investigational biologic drug for asthma or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
  • Patient has received treatment with any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.
  • Patient did not respond favorably to previous dupilumab treatment (e.g. therapy failure or patient experienced an adverse reaction to treatment).
  • Patient has received specific immunotherapy within 3 months prior to randomization. Note: If the patient has received immunotherapy, a 3 month washout period is required following the last dose of immunotherapy.
  • Patient is receiving medications or therapy that are prohibited as concomitant medications.
  • Patient has a known or suspected history of immunosuppression, including history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, HIV, listeriosis, pneumocystosis, pulmonary non-tuberculosis mycobacteria, or tuberculosis, regardless of infection resolution; or unusually frequent, recurrent, or prolonged infections. Note: Tuberculosis testing will be performed on a country-by-country basis according to local guidelines if required by regulatory authorities or ethics committees (ECs).
  • Patient has positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbsAqHBsAq), or hepatitis C antibody (HbsAqHBsAq) with positive HCV RNA polymerase chain reaction; or positive HIV serology at Screening.
  • Patient has a helminth parasitic infection diagnosed within 24 weeks prior to the date of informed consent that has not been treated with, or has failed to respond to, standard of care therapy.
  • Patient shows evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics, or antiprotozoals within 28 days of Screening, or significant viral infections within 28 days of Screening that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • Patient receives live (attenuated) vaccinations within 7 days of Screening or plans to receive live (attenuated) vaccinations during the study.
  • Patient has any disorder that is not stable in the opinion of the Investigator and may affect the safety of the patient throughout the study; influence the findings of the studies or their interpretations; or impede the patient's ability to complete the entire duration of study, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
  • Patient has any clinically significant abnormal findings in physical examination, vital signs, or safety lab tests during Screening/Run-in Period; or any significant medical history which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study.
  • Patient is being treated with immunosuppressive therapy or biologic therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis).
  • Patient has a prolonged corrected QT (QTc) interval (male > 450 milliseconds, female > 470 milliseconds) or tachyarrhythmia.
  • Patient has any of the following laboratory abnormalities at Screening:
  • Eosinophils > 1500 cells/mmE3 or 1.5*10E9/L
  • Platelets < 100000 cells/mmE3 or 100*10E9/L
  • Creatine phosphokinase (CPK) > 10 times the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) > 2.5 times the ULN
  • Aspartate aminotransferase (AST) ≥ 2.5 times the ULN
  • Bilirubin > 2 times the ULN.
  • Patient has a history of alcohol or drug abuse within 12 months of Screening.
  • Patient has an allergy to L-histidine, trehalose, or Tween (polysorbate) 80 or a history of a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
  • Patient has a history of malignancy within 5 years prior to the Baseline Visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix and nonmetastatic squamous or basal cell carcinoma of the skin are allowed.
  • Female patient is pregnant, planning to become pregnant, or is breastfeeding.

Trial locations and contacts

76 sites in 5 countries.

76 sites in 5 countries

United States39 sites

  • Connect Investigative Site 116

    Austin, Texas, 78759

  • Connect Investigative Site 124

    Bangor, Maine, 04401

  • Connect Investigative Site 119

    Bellevue, Nebraska, 78759

  • Connect Investigative Site 102

    Boerne, Texas, 78006

  • Connect Investigative Site 117

    Buffalo, New York, 14201

  • Connect Investigative Site 136

    Cincinnati, Ohio, 45236

  • Connect Investigative Site 121

    Dallas, Texas, 75231

  • Connect Investigative Site 107

    Edmond, Oklahoma, 73034

  • Connect Investigative Site 108

    El Paso, Texas, 79903

  • Connect Investigative Site 161

    Hialeah, Florida, 33012

  • Connect Investigative Site 114

    Hollywood, Florida, 33021

  • Connect Investigative Site 109

    Huntington Beach, California, 92647

  • Connect Investigative Site 143

    Huntington Beach, California, 92647

  • Connect Investigative Site 150

    Katy, Texas, 77450

  • Connect Investigative Site 132

    Lancaster, California, 93534

  • Connect Investigative Site 142

    Leesburg, Florida, 34748

  • Connect Investigative Site 104

    Miami, Florida, 33126

  • Connect Investigative Site 166

    Miami, Florida, 33145

  • Connect Investigative Site 118

    Miami, Florida, 33155

  • Connect Investigative Site 162

    Miami, Florida, 33155

  • Connect Investigative Site 163

    Miami, Florida, 33174

  • Connect Investigative Site 164

    Miami, Florida, 33174

  • Connect Investigative Site 105

    Miami, Florida, 33176

  • Connect Investigative Site 165

    Miami Gardens, Florida, 33014

  • Connect Investigative Site 110

    Miami Lakes, Florida, 33014

  • Connect Investigative Site 125

    Mission Viejo, California, 92691

  • Connect Investigative Site 153

    New York, New York, 10036

  • Connect Investigative Site 144

    North Las Vegas, Nevada, 89030

  • Connect Investigative Site 149

    Oklahoma City, Oklahoma, 73120

  • Connect Investigative Site 111

    Princeton, New Jersey, 08540

  • Connect Investigative Site 103

    San Jose, California, 95117

  • Connect Investigative Site 112

    St Louis, Missouri, 63141

  • Connect Investigative Site 147

    Toledo, Ohio, 43617

  • Connect Investigative Site 154

    Tucson, Arizona, 85704

  • Connect Investigative Site 129

    Warwick, Rhode Island, 02886

  • Connect Investigative Site 146

    West Bloomfield, Michigan, 48322

  • Connect Investigative Site 120

    White Marsh, Maryland, 21162

  • Connect Investigative Site 122

    Winston-Salem, North Carolina, 27104

  • Connect Investigative Site 123

    Winter Park, Florida, 32789

Other trials in United States

China22 sites

  • Connect Investigative Site 204

    Baotou, Inner Mongolia, 014000

  • Connect Investigative Site 214

    Baotou, Inner Mongolia, 14010

  • Connect Investigative Site 201

    Beijing, Beijing Municipality, 100029

  • Connect Investigative Site 216

    Beijing, Beijing Municipality, 100039

  • Connect Investigative Site 209

    Beijing, Beijing Municipality, 100730

  • Connect Investigative Site 215

    Beijing, Beijing Municipality, 101100

  • Connect Investigative Site 206

    Bengbu, Anhui, 233000

  • Connect Investigative Site 212

    Changchun, Jilin, 130021

  • Connect Investigative Site 202

    Changsha, Hunan, 410013

  • Connect Investigative Site 203

    Guangzhou, Guangdong, 510080

  • Connect Investigative Site 210

    Hohhot, Inner Mongolia, 010050

  • Connect Investigative Site 211

    Luoyang, Henan, 471003

  • Connect Investigative Site 217

    Ningbo, Zhejiang, 315046

  • Connect Investigative Site 207

    Shanghai, Shanghai Municipality, 200025

  • Connect Investigative Site 218

    Shanghai, Shanghai Municipality, 200433

  • Connect Investigative Site 220

    Shenyang, Liaoning, 11004

  • Connect Investigative Site 221

    Taiyuan, Shanxi, 030001

  • Connect Investigative Site 222

    Taiyuan, Shanxi, 030032

  • Connect Investigative Site 224

    Ürümqi, Xinjiang, 830054

  • Connect Investigative Site 213

    Wuhan, Hubei, 430000

  • Connect Investigative Site 205

    Wuxi, Jiangsu, 214023

  • Connect Investigative Site 208

    Yangzhou, Jiangsu, 225007

Other trials in China

Poland9 sites

  • Connect Investigative Site 404

    Bialystok, Podlaskie Voivodeship, 15-010

  • Connect Investigative Site 405

    Bialystok, Podlaskie Voivodeship, 15-010

  • Connect Investigative Site 410

    Częstochowa, Świętokrzyskie Voivodeship, 42-200

  • Connect Investigative Site 402

    Krakow, Lesser Poland Voivodeship, 30-033

  • Connect Investigative Site 401

    Krakow, Lesser Poland Voivodeship, 31-559

  • Connect Investigative Site 403

    Lubin, Lower Silesian Voivodeship, 59-300

  • Connect Investigative Site 407

    Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110

  • Connect Investigative Site 406

    Skierniewice, Lódzkie, 96-100

  • Connect Investigative Site 408

    Wroclaw, Lower Silesian Voivodeship, 53-301

Other trials in Poland

South Korea4 sites

  • Connect Investigative Site 505

    Incheon, Gyeonggi-do, 21565

  • Connect Investigative Site 503

    Seongnam-si, Gyeonggi-do, 13496

  • Connect Investigative Site 501

    Seoul, Seoul Teugbyeolsi, 03080

  • Connect Investigative Site 502

    Seoul, Seoul Teugbyeolsi, 03722

Other trials in South Korea

Hungary2 sites

  • Connect Investigative Site 304

    Püspökladány, Hajdú-Bihar, 4150

  • Connect Investigative Site 303

    Szombathely, Vas County, 9700

Other trials in Hungary

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Efficacy and Safety Study of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation

This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.

Read the detailed description

This is a multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two dose levels of CBP-201 administered to eligible patients with moderate to severe persistent asthma with Type 2 inflammation compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks.

Being tested
CBP-201, Placebo
Keywords
Type 2 inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP-201Drug

    Also called rademikibart

    CBP-201 subcutaneous (SC) injection.

  • PlaceboDrug

    Placebo subcutaneous (SC) injection.

Study groups in NCT04773678
Study groupRoleWhat they receive
CBP-201 Dose 1ExperimentalCBP-201 Dose 1 subcutaneous (SC) injection.
Receives: Drug: CBP-201
CBP-201 Dose 2ExperimentalCBP-201 Dose 2 subcutaneous (SC) injection.
Receives: Drug: CBP-201
PlaceboPlacebo comparatorPlacebo subcutaneous (SC) injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1)

    Absolute change from Baseline in prebronchodilator (trough) FEV1 at Week 12. To assess the efficacy of CBP-201 (Dose 1 and Dose 2) versus placebo in patients with moderate to severe persistent asthma with type 2 inflammation as measured by lung function improvements.

    Measured: at Week 12

Secondary outcomes (7)

  1. Absolute change in prebronchodilator (trough) FEV1

    Absolute change from Baseline in prebronchodilator (trough) FEV1 at Weeks 1, 2, 4, 8 and 24.

    Measured: at Weeks 1, 2, 4, 8 and 24

  2. Percent change in prebronchodilator (trough) FEV1

    Percent change from Baseline in prebronchodilator (trough) FEV1 at Weeks 1, 2, 4, 8, 12 and 24.

    Measured: at Weeks 1, 2, 4, 8, 12 and 24

  3. Change in other lung function measurements

    Change from Baseline in other lung function measurements [percentage predicted FEV1, morning and evening peak expiratory flow (PEF)].

    Measured: From Baseline to Week 24

  4. Time to severe exacerbation and number of events

    Time to severe exacerbation and number of events during the 24 weeks Treatment Period.

    Measured: From Baseline to Week 24

  5. Proportion of patients with ≥ 1 asthma exacerbation

    Proportion of patients with ≥ 1 asthma exacerbation during the 24 weeks Treatment Period.

    Measured: From Baseline to Week 24

  6. Incidence, type and severity of Adverse Event (AE)

    Safety endpoints will be summarized by descriptive statistics and narratives where indicated by severity. Safety will be assessed on basis of AEs reported, including SAEs and AESIs.

    Measured: From Baseline to Week 32

  7. Pharmacokinetics (Steady-state trough PK profile)

    Whole blood for plasma CBP-201 concentrations will be obtained and analyzed.

    Measured: From Baseline to Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start11 May 2021
  3. Primary completion5 Aug 2023
  4. Study completion28 Sep 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773678
Sponsor's protocol ID
CBP-201-WW002
Status last verified
Dec 2022
First submitted
24 Feb 2021
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wechsler ME, Quart B, Collazo R. Eosinophil Counts in Adults With Asthma Treated with Anti-IL-4Ralpha Rademikibart: Exploratory Analyses in a Randomized Trial. Chest. 2026 Apr 28:S0012-3692(26)00563-5. doi: 10.1016/j.chest.2026.04.019. Online ahead of print.

    PubMed 42061700

  • Kerwin E, Yang T, Su N, Guo J, Adivikolanu R, Longphre M, Wang J, Yun J, Pan W, Wei Z, Collazo R. Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 May;211(5):749-758. doi: 10.1164/rccm.202409-1708OC.

    PubMed 39998473

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBP-201 in people with Moderate to Severe Persistent Asthma, run by Connect Biopharm LLC at 76 sites in 5 countries.

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 23 inclusion and 35 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: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, China, Poland, South Korea, Hungary. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1) (time frame: at Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04773678, which also lists 2 linked publications.

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 29 Mar 2024.

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