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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CBP-201
Sponsored by
Suzhou Connect Biopharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Subjects have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an ICF. 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. 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. Any of the following laboratory test abnormalities at the screening visit: Aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; Serum creatinine > 1.2 × ULN; White blood cell count < 3.0 × 109/L or ≥ 14 × 109/L; Note: If the subjects have the above laboratory test abnormalities at screening, after being assessed as necessary by the investigator, they are allowed to receive a retest on another day within 28 days of the screening period, and those qualified for the retest are permitted to be enrolled (it is forbidden to conduct drug intervention for those laboratory test abnormalities before retest). History of hypersensitivity to L-histidine, trehalose or Tween (polysorbate) 80, or systemic hypersensitivity reactions to any biological agents (except local injection site reactions). History of alcohol or drug abuse within 2 years before D1 visit. Have been vaccinated with (attenuated) live vaccine within 8 weeks before D1 visit, or planning to be vaccinated during the study period. Planning to undergo major surgical operations during the study period. Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period. Any other conditions (e.g., those may increase the risks of the subjects, or may affect/interfere with the assessment of the study) that the investigator deems unsuitable for participation in this study, including but not limited to: prior or current physical or mental illness, clinically significant physical examination results, vital signs, or safety laboratory test abnormalities at screening. The specific reasons for subjects excluded due to this criterion will be indicated in the study documents (including medical records and electronic case report form (eCRF)).

Sites / Locations

  • Connect Investigative Site 01Recruiting
  • Connect Investigative Site 41
  • Connect Investigative Site 14
  • Connect Investigative Site 25Recruiting
  • Connect Investigative Site 03Recruiting
  • Connect Investigative Site 11Recruiting
  • Connect Investigative Site 13Recruiting
  • Connect Investigative Site 20Recruiting
  • Connect Investigative Site 22Recruiting
  • Connect Investigative Site 31Recruiting
  • Connect Investigative Site 16
  • Connect Investigative Site 17Recruiting
  • Connect Investigative Site 12Recruiting
  • Connect Investigative Site 19Recruiting
  • Connect Investigative Site 27Recruiting
  • Connect Investigative Site 28Recruiting
  • Connect Investigative Site 26Recruiting
  • Connect Investigative Site 34Recruiting
  • Connect Investigative Site 39
  • Connect Investigative Site 05Recruiting
  • Connect Investigative Site 29Recruiting
  • Connect Investigative Site 40Recruiting
  • Connect Investigative Site 24Recruiting
  • Connect Investigative Site 18Recruiting
  • Connect Investigative Site 30
  • Connect Investigative Site 21Recruiting
  • Connect Investigative Site 35Recruiting
  • Connect Investigative Site 36Recruiting
  • Connect Investigative Site 04Recruiting
  • Connect Investigative Site 10
  • Connect Investigative Site 06
  • Connect Investigative Site 15Recruiting
  • Connect Investigative Site 23Recruiting
  • Connect Investigative Site 02Recruiting
  • Connect Investigative Site 42
  • Connect Investigative Site 09Recruiting
  • Connect Investigative Site 07Recruiting
  • Connect Investigative Site 08Recruiting
  • Connect Investigative Site 33Recruiting
  • Connect Investigative Site 37Recruiting
  • Connect Investigative Site 38
  • Connect Investigative Site 32Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBP-201

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)
cases/person-years

Secondary Outcome Measures

Incidence of treatment-related treatment-emergent adverse events (TEAEs)
cases/person-years
Incidence of serious adverse events (SAEs)
cases/person-years
Incidence of treatment-related serious adverse events (SAEs)
cases/person-years
Incidence of adverse events of special interest (AESIs)
cases/person-years
Abnormal changes in vital signs
Vital signs (VS): including body temperature, respiration rate, blood pressure, and heart rate.
Abnormal changes in physical examination
Physical examination included are as follows: general appearance, skin, ears/nose/throat, head and neck, cardiovascular system, respiratory system, abdomen, limbs, lymph nodes, musculoskeletal and nervous systems.
Abnormal changes in laboratory tests: Hematology
White blood cell count, Hemoglobin, Hematocrit, Red blood cell count, Platelet count, Neutrophil percentage, Lymphocyte percentage, Monocyte percentage, Basophil percentage, Eosinophil percentage, Absolute neutrophil count, Absolute lymphocyte count, Absolute monocyte count, Absolute eosinophil count, Absolute basophil count
Abnormal changes in laboratory tests: Blood biochemistry
Sodium, Potassium, Calcium, Chlorine, Serum urea/urea nitrogen, Creatinine, Glucose, Total protein, Albumin, Total bilirubin, Alanine aminotransaminase, Aspartate aminotransferase, γ-glutamyltransferase, Alkaline phosphatase, Lactate dehydrogenase, Creatine phosphokinase, Total cholesterol, Low-density lipoprotein, High-density lipoprotein
Abnormal changes in laboratory tests: Urinalysis
Urine bilirubin, Urine red blood cells, Urine white blood cells, Urine glucose, Urine ketone, Urine nitrite, Urine pH, Urine protein, Urine specific gravity, Urobilinogen, Microscopic examination (if necessary)
Abnormal changes in electrocardiogram (ECG) parameters
ECG variables include ventricular heart rate and PR, QRS, QT, and QTcF intervals.
Proportion of subjects achieving greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI-75)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Proportion of subjects whose Investigator Global Assessment (IGA) score is 0-1 and decreased by ≥ 2 points from baseline
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Proportion of subjects achieving greater than or equal to 50% improvement in Eczema Area and Severity Index (EASI-50)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Proportion of subjects achieving greater than or equal to 90% improvement in Eczema Area and Severity Index (EASI-90)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Proportion of subjects achieving 100% improvement in Eczema Area and Severity Index (EASI-100)
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Proportion of subjects whose IGA score is decreased by ≥ 2 points from baseline
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Proportion of subjects with IGA score ≤ 2 (equivalent to reaching a low disease activity state)
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 3 points from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 4 points from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Change and percentage change in the EASI score from baseline
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Change and percentage change in the weekly average PP-NRS from baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Change and percentage change in the body surface area (BSA) affected by Atopic Dermatitis from baseline
The "Rule of Nines" is used to estimate the maximum percentage of Atopic Dermatitis-affected body surface area (BSA): head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%].
Change and percentage change in the Dermatology Life Quality Index (DLQI) score from baseline
Dermatology Life Quality Index (DLQI) is a questionnaire containing 10 items to assess the impact of Atopic Dermatitis on quality of life (QOL) in the past week, and the scores range from 0 (no disease) to 30 (severe disease); the higher the score, the worse the quality of life.
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis)
except emollients; the proportion will be summarized separately by all concomitant medications and the ATC2 codes for concomitant medications
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis) prohibited by the protocol
(except emollients; the proportion will be summarized separately by all concomitant medications, local therapy, systemic treatment, and the ATC2 codes for concomitant medications)
Proportion of subjects receiving topical corticosteroids (TCS) for the treatment of the disease under study (Atopic Dermatitis)
If topical corticosteroids (TCS) is considered necessary by the investigator.
Duration of TCS use for the treatment of the disease under study (Atopic Dermatitis)
days/person-years
Percentage of subjects positive for anti-drug antibody (ADA) and ADA titer range
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.
Percentage of subjects positive for neutralizing antibody (NAb) in subjects positive for ADA
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.

Full Information

First Posted
June 5, 2023
Last Updated
September 3, 2023
Sponsor
Suzhou Connect Biopharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05905133
Brief Title
A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Connect Biopharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBP-201
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
CBP-201
Other Intervention Name(s)
CBP-201 injection
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
cases/person-years
Time Frame
From Day 1 study drug first administrated to Week 20
Secondary Outcome Measure Information:
Title
Incidence of treatment-related treatment-emergent adverse events (TEAEs)
Description
cases/person-years
Time Frame
From Day 1 study drug first administrated to Week 20
Title
Incidence of serious adverse events (SAEs)
Description
cases/person-years
Time Frame
From Day 1 study drug first administrated to Week 20
Title
Incidence of treatment-related serious adverse events (SAEs)
Description
cases/person-years
Time Frame
From Day 1 study drug first administrated to Week 20
Title
Incidence of adverse events of special interest (AESIs)
Description
cases/person-years
Time Frame
From Day 1 study drug first administrated to Week 20
Title
Abnormal changes in vital signs
Description
Vital signs (VS): including body temperature, respiration rate, blood pressure, and heart rate.
Time Frame
Pre-dose, Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Title
Abnormal changes in physical examination
Description
Physical examination included are as follows: general appearance, skin, ears/nose/throat, head and neck, cardiovascular system, respiratory system, abdomen, limbs, lymph nodes, musculoskeletal and nervous systems.
Time Frame
Pre-dose, Day85, Day141
Title
Abnormal changes in laboratory tests: Hematology
Description
White blood cell count, Hemoglobin, Hematocrit, Red blood cell count, Platelet count, Neutrophil percentage, Lymphocyte percentage, Monocyte percentage, Basophil percentage, Eosinophil percentage, Absolute neutrophil count, Absolute lymphocyte count, Absolute monocyte count, Absolute eosinophil count, Absolute basophil count
Time Frame
Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Title
Abnormal changes in laboratory tests: Blood biochemistry
Description
Sodium, Potassium, Calcium, Chlorine, Serum urea/urea nitrogen, Creatinine, Glucose, Total protein, Albumin, Total bilirubin, Alanine aminotransaminase, Aspartate aminotransferase, γ-glutamyltransferase, Alkaline phosphatase, Lactate dehydrogenase, Creatine phosphokinase, Total cholesterol, Low-density lipoprotein, High-density lipoprotein
Time Frame
Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Title
Abnormal changes in laboratory tests: Urinalysis
Description
Urine bilirubin, Urine red blood cells, Urine white blood cells, Urine glucose, Urine ketone, Urine nitrite, Urine pH, Urine protein, Urine specific gravity, Urobilinogen, Microscopic examination (if necessary)
Time Frame
Pre-dose, Day1, Day15, Day29, Day57, Day85, Day141
Title
Abnormal changes in electrocardiogram (ECG) parameters
Description
ECG variables include ventricular heart rate and PR, QRS, QT, and QTcF intervals.
Time Frame
Pre-dose, Day1, Day141
Title
Proportion of subjects achieving greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI-75)
Description
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects whose Investigator Global Assessment (IGA) score is 0-1 and decreased by ≥ 2 points from baseline
Description
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects achieving greater than or equal to 50% improvement in Eczema Area and Severity Index (EASI-50)
Description
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects achieving greater than or equal to 90% improvement in Eczema Area and Severity Index (EASI-90)
Description
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects achieving 100% improvement in Eczema Area and Severity Index (EASI-100)
Description
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects whose IGA score is decreased by ≥ 2 points from baseline
Description
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects with IGA score ≤ 2 (equivalent to reaching a low disease activity state)
Description
The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 3 points from baseline
Description
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Time Frame
Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Title
Proportion of subjects whose weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) is decreased by ≥ 4 points from baseline
Description
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Time Frame
Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Title
Change and percentage change in the EASI score from baseline
Description
The Eczema Area and Severity Index (EASI) scale quantifies the severity and extent of Atopic Dermatitis, as well as the severity of erythema, infiltration, excoriation, and lichenification of the four anatomical regions-head and neck, trunk, upper extremities, and lower extremities.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Change and percentage change in the weekly average PP-NRS from baseline
Description
Peak Pruritus Numerical Rating Scale (PP-NRS) is a single self-reported item designed to measure the peak pruritus or the "worst" pruritus in the previous 24 hours.
Time Frame
Day1, Day15, Day29, Day43, Day57, Day71, Day85, Day113, Day141
Title
Change and percentage change in the body surface area (BSA) affected by Atopic Dermatitis from baseline
Description
The "Rule of Nines" is used to estimate the maximum percentage of Atopic Dermatitis-affected body surface area (BSA): head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%].
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Change and percentage change in the Dermatology Life Quality Index (DLQI) score from baseline
Description
Dermatology Life Quality Index (DLQI) is a questionnaire containing 10 items to assess the impact of Atopic Dermatitis on quality of life (QOL) in the past week, and the scores range from 0 (no disease) to 30 (severe disease); the higher the score, the worse the quality of life.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day113, Day141
Title
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis)
Description
except emollients; the proportion will be summarized separately by all concomitant medications and the ATC2 codes for concomitant medications
Time Frame
from Day1 to Week12
Title
Proportion of subjects receiving concomitant medications for the treatment of the disease under study (Atopic Dermatitis) prohibited by the protocol
Description
(except emollients; the proportion will be summarized separately by all concomitant medications, local therapy, systemic treatment, and the ATC2 codes for concomitant medications)
Time Frame
from Day1 to Week12
Title
Proportion of subjects receiving topical corticosteroids (TCS) for the treatment of the disease under study (Atopic Dermatitis)
Description
If topical corticosteroids (TCS) is considered necessary by the investigator.
Time Frame
from Day1 to Week12
Title
Duration of TCS use for the treatment of the disease under study (Atopic Dermatitis)
Description
days/person-years
Time Frame
from Day1 to Week12
Title
Percentage of subjects positive for anti-drug antibody (ADA) and ADA titer range
Description
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day141
Title
Percentage of subjects positive for neutralizing antibody (NAb) in subjects positive for ADA
Description
Descriptive statistics will be used to summarize the baseline values of related measurements (ADA, NAb) and the changes from baseline to each visit.
Time Frame
Day1, Day15, Day29, Day57, Day85, Day141

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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. Subjects have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an ICF. 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. 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. Any of the following laboratory test abnormalities at the screening visit: Aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; Serum creatinine > 1.2 × ULN; White blood cell count < 3.0 × 109/L or ≥ 14 × 109/L; Note: If the subjects have the above laboratory test abnormalities at screening, after being assessed as necessary by the investigator, they are allowed to receive a retest on another day within 28 days of the screening period, and those qualified for the retest are permitted to be enrolled (it is forbidden to conduct drug intervention for those laboratory test abnormalities before retest). History of hypersensitivity to L-histidine, trehalose or Tween (polysorbate) 80, or systemic hypersensitivity reactions to any biological agents (except local injection site reactions). History of alcohol or drug abuse within 2 years before D1 visit. Have been vaccinated with (attenuated) live vaccine within 8 weeks before D1 visit, or planning to be vaccinated during the study period. Planning to undergo major surgical operations during the study period. Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period. Any other conditions (e.g., those may increase the risks of the subjects, or may affect/interfere with the assessment of the study) that the investigator deems unsuitable for participation in this study, including but not limited to: prior or current physical or mental illness, clinically significant physical examination results, vital signs, or safety laboratory test abnormalities at screening. The specific reasons for subjects excluded due to this criterion will be indicated in the study documents (including medical records and electronic case report form (eCRF)).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peipei Liu
Phone
(+86)0512-53577866
Email
ppliu@connectpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzhou Connect
Organizational Affiliation
Suzhou Connect Biopharmaceuticals, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Connect Investigative Site 01
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 41
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 14
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 25
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 03
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 11
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 13
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 20
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 22
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 31
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 16
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 17
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 12
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 19
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 27
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 28
City
Yichang
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 26
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 34
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 39
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 05
City
Zhenjiang
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 29
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 40
City
Jiangxi
State/Province
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 24
City
Baotou
State/Province
Nei Monggol
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 18
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 30
City
Dongying
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 21
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 35
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 36
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 04
City
Taiyuan
State/Province
Shangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 10
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 06
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 15
City
Yuncheng
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 23
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 02
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 42
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 09
City
Ürümqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 07
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 08
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 33
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 37
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Connect Investigative Site 38
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Connect Investigative Site 32
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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