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

NCT ID: NCT04773678

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2023-09-28

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.

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.

Conditions

Moderate to Severe Persistent Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CBP-201 Dose 1

CBP-201 Dose 1 subcutaneous (SC) injection.

Group Type: EXPERIMENTAL

CBP-201

Intervention Type: DRUG

CBP-201 subcutaneous (SC) injection.

CBP-201 Dose 2

CBP-201 Dose 2 subcutaneous (SC) injection.

Group Type: EXPERIMENTAL

CBP-201

Intervention Type: DRUG

CBP-201 subcutaneous (SC) injection.

Placebo

Placebo subcutaneous (SC) injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo subcutaneous (SC) injection.

Interventions

CBP-201

CBP-201 subcutaneous (SC) injection.

Intervention Type: DRUG

Placebo

Placebo subcutaneous (SC) injection.

Intervention Type: DRUG

Other Intervention Names

rademikibart

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. Blood eosinophil count ≥ 300 cells/μL at Screening.

6. Asthma Control Questionnaire, 6-question (ACQ-6) score ≥ 1.5 at Screening and Baseline.

7. 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.

8. Patient demonstrates acceptable inhaler, peak flow meter, and spirometry techniques during the Screening Period in the opinion of the Investigator.

9. 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.

10. 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.

11. Patient is able to understand and willing to sign the informed consent form (ICF).

12. Patient is willing and able to comply with clinic visit schedule and study-related procedures, in the opinion of the Investigator.

13. 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.

14. 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.

Exclusion Criteria

-

A patient who meets any of the following criteria will be ineligible to participate in this study:

15. 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).

16. 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.

17. 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.

18. Current smoker or former smoker with a smoking history of > 10 pack-years. Note: This includes tobacco, marijuana, and vaping products.

19. Patient is undergoing or planning to undergo any elective surgery during the study requiring general anesthesia.

20. 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.

21. Patient has received treatment with any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.

22. Patient did not respond favorably to previous dupilumab treatment (e.g. therapy failure or patient experienced an adverse reaction to treatment).

23. 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.

24. Patient is receiving medications or therapy that are prohibited as concomitant medications.

25. 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).

26. 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.

27. 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.

28. 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).

29. Patient receives live (attenuated) vaccinations within 7 days of Screening or plans to receive live (attenuated) vaccinations during the study.

30. 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.

31. 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.

32. 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).

33. Patient has a prolonged corrected QT (QTc) interval (male > 450 milliseconds, female > 470 milliseconds) or tachyarrhythmia.

34. 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.

35. Patient has a history of alcohol or drug abuse within 12 months of Screening.

36. 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.

37. 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.

38. Female patient is pregnant, planning to become pregnant, or is breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connect Biopharm LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzhou Connect

Role: STUDY_DIRECTOR

Connect Biopharm LLC

Locations

Connect Investigative Site 154

Tucson, Arizona, United States

Connect Investigative Site 109

Huntington Beach, California, United States

Connect Investigative Site 143

Huntington Beach, California, United States

Connect Investigative Site 132

Lancaster, California, United States

Connect Investigative Site 125

Mission Viejo, California, United States

Connect Investigative Site 103

San Jose, California, United States

Connect Investigative Site 161

Hialeah, Florida, United States

Connect Investigative Site 114

Hollywood, Florida, United States

Connect Investigative Site 142

Leesburg, Florida, United States

Connect Investigative Site 104

Miami, Florida, United States

Connect Investigative Site 166

Miami, Florida, United States

Connect Investigative Site 118

Miami, Florida, United States

Connect Investigative Site 162

Miami, Florida, United States

Connect Investigative Site 163

Miami, Florida, United States

Connect Investigative Site 164

Miami, Florida, United States

Connect Investigative Site 105

Miami, Florida, United States

Connect Investigative Site 165

Miami Gardens, Florida, United States

Connect Investigative Site 110

Miami Lakes, Florida, United States

Connect Investigative Site 123

Winter Park, Florida, United States

Connect Investigative Site 124

Bangor, Maine, United States

Connect Investigative Site 120

White Marsh, Maryland, United States

Connect Investigative Site 146

West Bloomfield, Michigan, United States

Connect Investigative Site 112

St Louis, Missouri, United States

Connect Investigative Site 119

Bellevue, Nebraska, United States

Connect Investigative Site 144

North Las Vegas, Nevada, United States

Connect Investigative Site 111

Princeton, New Jersey, United States

Connect Investigative Site 117

Buffalo, New York, United States

Connect Investigative Site 153

New York, New York, United States

Connect Investigative Site 122

Winston-Salem, North Carolina, United States

Connect Investigative Site 136

Cincinnati, Ohio, United States

Connect Investigative Site 147

Toledo, Ohio, United States

Connect Investigative Site 107

Edmond, Oklahoma, United States

Connect Investigative Site 149

Oklahoma City, Oklahoma, United States

Connect Investigative Site 129

Warwick, Rhode Island, United States

Connect Investigative Site 116

Austin, Texas, United States

Connect Investigative Site 102

Boerne, Texas, United States

Connect Investigative Site 121

Dallas, Texas, United States

Connect Investigative Site 108

El Paso, Texas, United States

Connect Investigative Site 150

Katy, Texas, United States

Connect Investigative Site 206

Bengbu, Anhui, China

Connect Investigative Site 201

Beijing, Beijing Municipality, China

Connect Investigative Site 216

Beijing, Beijing Municipality, China

Connect Investigative Site 209

Beijing, Beijing Municipality, China

Connect Investigative Site 215

Beijing, Beijing Municipality, China

Connect Investigative Site 203

Guangzhou, Guangdong, China

Connect Investigative Site 211

Luoyang, Henan, China

Connect Investigative Site 213

Wuhan, Hubei, China

Connect Investigative Site 202

Changsha, Hunan, China

Connect Investigative Site 204

Baotou, Inner Mongolia, China

Connect Investigative Site 214

Baotou, Inner Mongolia, China

Connect Investigative Site 210

Hohhot, Inner Mongolia, China

Connect Investigative Site 205

Wuxi, Jiangsu, China

Connect Investigative Site 208

Yangzhou, Jiangsu, China

Connect Investigative Site 212

Changchun, Jilin, China

Connect Investigative Site 220

Shenyang, Liaoning, China

Connect Investigative Site 207

Shanghai, Shanghai Municipality, China

Connect Investigative Site 218

Shanghai, Shanghai Municipality, China

Connect Investigative Site 221

Taiyuan, Shanxi, China

Connect Investigative Site 222

Taiyuan, Shanxi, China

Connect Investigative Site 224

Ürümqi, Xinjiang, China

Connect Investigative Site 217

Ningbo, Zhejiang, China

Connect Investigative Site 304

Püspökladány, Hajdú-Bihar, Hungary

Connect Investigative Site 303

Szombathely, Vas County, Hungary

Connect Investigative Site 402

Krakow, Lesser Poland Voivodeship, Poland

Connect Investigative Site 401

Krakow, Lesser Poland Voivodeship, Poland

Connect Investigative Site 403

Lubin, Lower Silesian Voivodeship, Poland

Connect Investigative Site 408

Wroclaw, Lower Silesian Voivodeship, Poland

Connect Investigative Site 406

Skierniewice, Lódzkie, Poland

Connect Investigative Site 404

Bialystok, Podlaskie Voivodeship, Poland

Connect Investigative Site 405

Bialystok, Podlaskie Voivodeship, Poland

Connect Investigative Site 410

Częstochowa, Świętokrzyskie Voivodeship, Poland

Connect Investigative Site 407

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Poland

Connect Investigative Site 505

Incheon, Gyeonggi-do, South Korea

Connect Investigative Site 503

Seongnam-si, Gyeonggi-do, South Korea

Connect Investigative Site 501

Seoul, Seoul Teugbyeolsi, South Korea

Connect Investigative Site 502

Seoul, Seoul Teugbyeolsi, South Korea

Countries

United States; China; Hungary; Poland; South Korea

References

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 Trial. Am J Respir Crit Care Med. 2025 Feb 25;211(5):749-58. doi: 10.1164/rccm.202409-1708OC. Online ahead of print.

Reference Type: DERIVED

PMID: 39998473 (View on PubMed)

Other Identifiers

CBP-201-WW002

Identifier Type: -

Identifier Source: org_study_id