A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD

NCT05905133 | Unknown Phase 2

• 1 other identifier: CBP-201-CN003
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 38

Brief Summary

This study is a single-arm, open-label, multi-center clinical study designed to assess the safety and efficacy of CBP-201 in eligible subjects with moderate to severe Atopic Dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  cases/person-years

  From Day 1 study drug first administrated to Week 20

Secondary Outcomes (29)

• Incidence of treatment-related treatment-emergent adverse events (TEAEs)

  From Day 1 study drug first administrated to Week 20

• Incidence of serious adverse events (SAEs)

  From Day 1 study drug first administrated to Week 20

• Incidence of treatment-related serious adverse events (SAEs)

  From Day 1 study drug first administrated to Week 20

• Incidence of adverse events of special interest (AESIs)

  From Day 1 study drug first administrated to Week 20

• Abnormal changes in vital signs

  Pre-dose, Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141

Study Arms (1)

CBP-201

EXPERIMENTAL

The subjects will receive CBP-201 600 mg (4 mL in total, 2 injections of 2 mL each in different sites) on Day1, begin to receive a subcutaneous injection of CBP-201 300 mg (2 mL) from Week2, and receive CBP-201 300 mg (2 mL) every 2 weeks thereafter until Week10.

Drug: CBP-201

Interventions

CBP-201 DRUG

subcutaneous injection

Also known as: CBP-201 injection

CBP-201

Eligibility Criteria

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

You may qualify if:

• ≤ age ≤ 75 years at the screening visit, male or female.
• Diagnosed with atopic dermatitis (according to the American Academy of Dermatology's Guidelines of care for the management of atopic dermatitis, 2014\[1\]) at the time of screening, and meeting all the 4 criteria below:
• Suffering from the disease for more than 1 year at the time of screening;
• At the screening and baseline visit, IGA score ≥ 3 (according to the validated Investigator Global Assessment for Atopic Dermatitis \[vIGA-AD™\] scale);
• EASI score ≥ 12;
• Percentage of total BSA affected by AD ≥ 10%.
• Female subjects of childbearing potential (FCBP) and male subjects who have not undergone vasectomy must agree to take highly effective contraceptive measures during the entire study period (from the signing of informed consent forms (ICFs) to the 8-week follow-up period after discontinuation of study drug). Postmenopausal women (determined by testing follicle stimulating hormone \[FSH\]; defined as the women who have had amenorrhea for at least 12 consecutive months without using drugs known to cause amenorrhea, and have a recorded FSH level greater than 40 mIU/mL or in the postmenopausal range) and women with a record of surgical sterilization (i.e., tubal ligation or hysterectomy or bilateral oophorectomy) before the screening visit can be considered infertile.
• Highly effective contraceptive measures include:
• i. Abstinence (acceptable only if it is part of the subject's routine lifestyle); ii. Hormones (oral, patch, ring, injection, implant) combined with male condoms. This measure must be used at least 30 days before the first study drug administration. Otherwise, another acceptable method of contraception must be used; iii. Intrauterine device (IUD) combined with male condoms.
• Subjects are willing and able to comply with study visits and related procedures.
• Subjects have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an ICF.

You may not qualify if:

• Received prior treatment with anti-interleukin-4 receptor α (IL-4Rα)/anti-interleukin-13 (IL-13) antibodies with a poor response (including treatment failure or development of unacceptable treatment-related adverse reactions).
• Have received any of the following topical treatments within 2 weeks before D1 visit: phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, or aromatic hydrocarbon receptor agonists.
• Have received systemic treatment with corticosteroids (except for corticosteroid inhalers and nasal sprays) or other immunosuppressive/immunomodulatory agents (including but not limited to cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, JAK inhibitors, and various biological agents) within 2 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
• Have received treatment with immune cell depletion agents (e.g., rituximab) within 6 months before D1 visit.
• Have received any investigational drug/treatment within 4 weeks before D1 visit or 5 drug half-lives (if known), whichever is longer.
• Other skin complications in addition to AD that may interfere with the study assessments.
• There is a known or suspected history of immunosuppression/immunodeficiency within 6 months before D1 visit (including but not limited to a history of invasive opportunistic infections, such as aspergillosis, coccidiosis, histoplasmosis, acquired immunodeficiency syndrome (AIDS), listeriosis, or Pneumocystis, even if the infection has subsided), or there is an abnormally frequently recurrent or persistent infection.
• Received systemic treatment with anti-infective drugs (including but not limited to antibiotics, antiviral drugs, antiparasitic drugs, antiprotozoal drugs, or antifungal drugs) due to acute or chronic infection within 1 week before D1 visit (after the infection subsides, the subjects can be rescreened).
• History of malignant tumor within 5 years before D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma).
• History of parasite infection within 6 months before D1 visit.
• Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and HBV-DNA, or positive for hepatitis C antibody and HCV ribonucleic acid (RNA) polymerase chain reaction, or serologically positive for human immunodeficiency virus (HIV) at the screening visit.
• Subjects with active tuberculosis, latent tuberculosis, or a history of nontuberculous mycobacterial infection at screening;
• Note:
• Unless there is a clear medical record proving that the subject has received adequate treatment and is currently able to start receiving biological treatment (based on the medical judgment of the investigator and/or infectious disease specialist);
• If needed, an interferon gamma release assay may be used to assist diagnosis of suspected tuberculosis.

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (38)

Connect Investigative Site 01

Beijing, Beijing Municipality, China

Location

Connect Investigative Site 41

Beijing, Beijing Municipality, China

Location

Connect Investigative Site 14

Fuzhou, Fujian, China

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Connect Investigative Site 25

Fuzhou, Fujian, China

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Connect Investigative Site 03

Guangzhou, Guangdong, China

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Connect Investigative Site 11

Guangzhou, Guangdong, China

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Connect Investigative Site 13

Guangzhou, Guangdong, China

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Connect Investigative Site 20

Guangzhou, Guangdong, China

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Connect Investigative Site 22

Shenzhen, Guangdong, China

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Connect Investigative Site 31

Nanning, Guangxi, China

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Connect Investigative Site 16

Haikou, Hainan, China

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Connect Investigative Site 17

Haikou, Hainan, China

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Connect Investigative Site 19

Nanyang, Henan, China

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Connect Investigative Site 27

Wuhan, Hubei, China

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Connect Investigative Site 28

Yichang, Hubei, China

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Connect Investigative Site 26

Changsha, Hunan, China

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Connect Investigative Site 34

Nanjing, Jiangsu, China

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Connect Investigative Site 39

Suzhou, Jiangsu, China

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Connect Investigative Site 05

Zhenjiang, Jiangsu, China

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Connect Investigative Site 29

Shenyang, Liaoning, China

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Connect Investigative Site 40

Jiangxi, Nanchang, China

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Connect Investigative Site 24

Baotou, Nei Monggol, China

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Connect Investigative Site 18

Yinchuan, Ningxia, China

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Connect Investigative Site 30

Dongying, Shandong, China

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Connect Investigative Site 21

Jinan, Shandong, China

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Connect Investigative Site 35

Jinan, Shandong, China

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Connect Investigative Site 36

Shanghai, Shanghai Municipality, China

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Connect Investigative Site 10

Taiyuan, Shanxi, China

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Connect Investigative Site 06

Xi’an, Shanxi, China

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Connect Investigative Site 15

Yuncheng, Shanxi, China

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Connect Investigative Site 23

Chengdu, Sichuan, China

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Connect Investigative Site 02

Tianjin, Tianjin Municipality, China

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Connect Investigative Site 09

Ürümqi, Xinjiang, China

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Connect Investigative Site 07

Hangzhou, Zhejiang, China

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Connect Investigative Site 08

Hangzhou, Zhejiang, China

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Connect Investigative Site 33

Hangzhou, Zhejiang, China

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Connect Investigative Site 37

Hangzhou, Zhejiang, China

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Connect Investigative Site 32

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

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: June 5, 2023
• First Posted: June 15, 2023
• Study Start: July 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

CN (38)