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

NCT04773678 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CBP-201-WW002
• Study Type: interventional
• Target: 322
• Locations: 5 countries
• Sites: 76

Brief 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.

Conditions

Moderate to Severe Persistent Asthma

Keywords

Type 2 inflammation

Outcome Measures

Primary Outcomes (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.

  at Week 12

Secondary Outcomes (7)

• Absolute change in prebronchodilator (trough) FEV1

  at Weeks 1, 2, 4, 8 and 24

• Percent change in prebronchodilator (trough) FEV1

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

• Change in other lung function measurements

  From Baseline to Week 24

• Time to severe exacerbation and number of events

  From Baseline to Week 24

• Proportion of patients with ≥ 1 asthma exacerbation

  From Baseline to Week 24

Study Arms (3)

CBP-201 Dose 1

EXPERIMENTAL

CBP-201 Dose 1 subcutaneous (SC) injection.

Drug: CBP-201

CBP-201 Dose 2

EXPERIMENTAL

CBP-201 Dose 2 subcutaneous (SC) injection.

Drug: CBP-201

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

CBP-201 DRUG

CBP-201 subcutaneous (SC) injection.

Also known as: rademikibart

CBP-201 Dose 1; CBP-201 Dose 2

Placebo DRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (76)

Connect Investigative Site 154

Tucson, Arizona, 85704, United States

Location

Connect Investigative Site 109

Huntington Beach, California, 92647, United States

Location

Connect Investigative Site 143

Huntington Beach, California, 92647, United States

Location

Connect Investigative Site 132

Lancaster, California, 93534, United States

Location

Connect Investigative Site 125

Mission Viejo, California, 92691, United States

Location

Connect Investigative Site 103

San Jose, California, 95117, United States

Location

Connect Investigative Site 161

Hialeah, Florida, 33012, United States

Location

Connect Investigative Site 114

Hollywood, Florida, 33021, United States

Location

Connect Investigative Site 142

Leesburg, Florida, 34748, United States

Location

Connect Investigative Site 104

Miami, Florida, 33126, United States

Location

Connect Investigative Site 166

Miami, Florida, 33145, United States

Location

Connect Investigative Site 118

Miami, Florida, 33155, United States

Location

Connect Investigative Site 162

Miami, Florida, 33155, United States

Location

Connect Investigative Site 163

Miami, Florida, 33174, United States

Location

Connect Investigative Site 164

Miami, Florida, 33174, United States

Location

Connect Investigative Site 105

Miami, Florida, 33176, United States

Location

Connect Investigative Site 165

Miami Gardens, Florida, 33014, United States

Location

Connect Investigative Site 110

Miami Lakes, Florida, 33014, United States

Location

Connect Investigative Site 123

Winter Park, Florida, 32789, United States

Location

Connect Investigative Site 124

Bangor, Maine, 04401, United States

Location

Connect Investigative Site 120

White Marsh, Maryland, 21162, United States

Location

Connect Investigative Site 146

West Bloomfield, Michigan, 48322, United States

Location

Connect Investigative Site 112

St Louis, Missouri, 63141, United States

Location

Connect Investigative Site 119

Bellevue, Nebraska, 78759, United States

Location

Connect Investigative Site 144

North Las Vegas, Nevada, 89030, United States

Location

Connect Investigative Site 111

Princeton, New Jersey, 08540, United States

Location

Connect Investigative Site 117

Buffalo, New York, 14201, United States

Location

Connect Investigative Site 153

New York, New York, 10036, United States

Location

Connect Investigative Site 122

Winston-Salem, North Carolina, 27104, United States

Location

Connect Investigative Site 136

Cincinnati, Ohio, 45236, United States

Location

Connect Investigative Site 147

Toledo, Ohio, 43617, United States

Location

Connect Investigative Site 107

Edmond, Oklahoma, 73034, United States

Location

Connect Investigative Site 149

Oklahoma City, Oklahoma, 73120, United States

Location

Connect Investigative Site 129

Warwick, Rhode Island, 02886, United States

Location

Connect Investigative Site 116

Austin, Texas, 78759, United States

Location

Connect Investigative Site 102

Boerne, Texas, 78006, United States

Location

Connect Investigative Site 121

Dallas, Texas, 75231, United States

Location

Connect Investigative Site 108

El Paso, Texas, 79903, United States

Location

Connect Investigative Site 150

Katy, Texas, 77450, United States

Location

Connect Investigative Site 206

Bengbu, Anhui, 233000, China

Location

Connect Investigative Site 201

Beijing, Beijing Municipality, 100029, China

Location

Connect Investigative Site 216

Beijing, Beijing Municipality, 100039, China

Location

Connect Investigative Site 209

Beijing, Beijing Municipality, 100730, China

Location

Connect Investigative Site 215

Beijing, Beijing Municipality, 101100, China

Location

Connect Investigative Site 203

Guangzhou, Guangdong, 510080, China

Location

Connect Investigative Site 211

Luoyang, Henan, 471003, China

Location

Connect Investigative Site 213

Wuhan, Hubei, 430000, China

Location

Connect Investigative Site 202

Changsha, Hunan, 410013, China

Location

Connect Investigative Site 204

Baotou, Inner Mongolia, 014000, China

Location

Connect Investigative Site 214

Baotou, Inner Mongolia, 14010, China

Location

Connect Investigative Site 210

Hohhot, Inner Mongolia, 010050, China

Location

Connect Investigative Site 205

Wuxi, Jiangsu, 214023, China

Location

Connect Investigative Site 208

Yangzhou, Jiangsu, 225007, China

Location

Connect Investigative Site 212

Changchun, Jilin, 130021, China

Location

Connect Investigative Site 220

Shenyang, Liaoning, 11004, China

Location

Connect Investigative Site 207

Shanghai, Shanghai Municipality, 200025, China

Location

Connect Investigative Site 218

Shanghai, Shanghai Municipality, 200433, China

Location

Connect Investigative Site 221

Taiyuan, Shanxi, 030001, China

Location

Connect Investigative Site 222

Taiyuan, Shanxi, 030032, China

Location

Connect Investigative Site 224

Ürümqi, Xinjiang, 830054, China

Location

Connect Investigative Site 217

Ningbo, Zhejiang, 315046, China

Location

Connect Investigative Site 304

Püspökladány, Hajdú-Bihar, 4150, Hungary

Location

Connect Investigative Site 303

Szombathely, Vas County, 9700, Hungary

Location

Connect Investigative Site 402

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Connect Investigative Site 401

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Connect Investigative Site 403

Lubin, Lower Silesian Voivodeship, 59-300, Poland

Location

Connect Investigative Site 408

Wroclaw, Lower Silesian Voivodeship, 53-301, Poland

Location

Connect Investigative Site 406

Skierniewice, Lódzkie, 96-100, Poland

Location

Connect Investigative Site 404

Bialystok, Podlaskie Voivodeship, 15-010, Poland

Location

Connect Investigative Site 405

Bialystok, Podlaskie Voivodeship, 15-010, Poland

Location

Connect Investigative Site 410

Częstochowa, Świętokrzyskie Voivodeship, 42-200, Poland

Location

Connect Investigative Site 407

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110, Poland

Location

Connect Investigative Site 505

Incheon, Gyeonggi-do, 21565, South Korea

Location

Connect Investigative Site 503

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Connect Investigative Site 501

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Connect Investigative Site 502

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39998473 DERIVED

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: May 11, 2021
• Primary Completion: August 5, 2023
• Study Completion: September 28, 2023
• Last Updated: March 29, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (39); PL (9); CN (22); KR (4); HU (2)