A Multi-Center, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe Atopic Dermatitis

Suzhou Connect Biopharmaceuticals, Ltd.38 sites in 1 country360 target enrollmentJuly 15, 2023

ConditionsAtopic Dermatitis

InterventionsCBP-201

Overview

Phase: Phase 2
Intervention: CBP-201
Conditions: Atopic Dermatitis
Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Enrollment: 360
Locations: 38
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

The study includes a screening period, a treatment period and a follow-up period. The subjects will receive a subcutaneous injection of 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.

Registry

clinicaltrials.gov

Start Date

July 15, 2023

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Connect Biopharmaceuticals, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 ≤ 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.

Exclusion Criteria

•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.

Arms & Interventions

CBP-201

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.

Intervention: CBP-201

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame: From Day 1 study drug first administrated to Week 20

cases/person-years

Secondary Outcomes

Incidence of treatment-related treatment-emergent adverse events (TEAEs)(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)
Abnormal changes in physical examination(Pre-dose, Day85, Day141)
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 4 points from baseline(Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141)
Change and percentage change in the weekly average PP-NRS from baseline(Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141)
Change and percentage change in the body surface area (BSA) affected by Atopic Dermatitis from baseline(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Change and percentage change in the Dermatology Life Quality Index (DLQI) score from baseline(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis)(from Day1 to Week12)
Abnormal changes in laboratory tests: Hematology(Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141)
Abnormal changes in electrocardiogram (ECG) parameters(Pre-dose, Day1, Day141)
Proportion of subjects whose Investigator Global Assessment (IGA) score is 0-1 and decreased by ≥ 2 points from baseline(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects whose IGA score is decreased by ≥ 2 points from baseline(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects receiving topical corticosteroids (TCS) for the treatment of the disease under study (Atopic Dermatitis)(from Day1 to Week12)
Abnormal changes in laboratory tests: Blood biochemistry(Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141)
Incidence of serious adverse events (SAEs)(From Day 1 study drug first administrated to Week 20)
Percentage of subjects positive for neutralizing antibody (NAb) in subjects positive for ADA(Day1, Day15, Day29, Day57, Day85, Day141)
Abnormal changes in laboratory tests: Urinalysis(Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141)
Proportion of subjects achieving greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI-75)(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects achieving greater than or equal to 50% improvement in Eczema Area and Severity Index (EASI-50)(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects achieving greater than or equal to 90% improvement in Eczema Area and Severity Index (EASI-90)(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects achieving 100% improvement in Eczema Area and Severity Index (EASI-100)(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects with IGA score ≤ 2 (equivalent to reaching a low disease activity state)(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 3 points from baseline(Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141)
Change and percentage change in the EASI score from baseline(Day1, Day15, Day29, Day57, Day85, Day113, Day141)
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis) prohibited by the protocol(from Day1 to Week12)
Duration of TCS use for the treatment of the disease under study (Atopic Dermatitis)(from Day1 to Week12)
Percentage of subjects positive for anti-drug antibody (ADA) and ADA titer range(Day1, Day15, Day29, Day57, Day85, Day141)