A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China

A Double-blind, Multi-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of CBP-201 in Chinese Subjects With Moderate to Severe Atopic Dermatitis

This study will evaluate the efficacy and safety of CBP-201 in Chinese subjects with moderate to severe atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: CBP-201

Detailed Description

This study is a randomized, double-blind, multi-center, controlled study designed to assess the efficacy, safety and PK characteristics of CBP-201 in eligible subjects with moderate to severe AD.

The study includes a screening period, a treatment period and a follow-up period. The treatment period is divided into two stages.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Connect Investigative Site 33
  • Beijing
    • Beijing, Beijing, China
      • Connect Investigative Site 01
    • Beijing, Beijing, China
      • Connect Investigative Site 02
    • Beijing, Beijing, China
      • Connect Investigative Site 03
    • Beijing, Beijing, China
      • Connect Investigative Site 17
    • Beijing, Beijing, China
      • Connect Investigative Site 47
  • Chongqing
    • Chongqing, Chongqing, China
      • Connect Investigative Site 28
    • Chongqing, Chongqing, China
      • Connect Investigative Site 29
    • Chongqing, Chongqing, China
      • Connect Investigative Site 30
    • Chongqing, Chongqing, China
      • Connect Investigative Site 36
  • Fujian
    • Fuzhou, Fujian, China
      • Connect Investigative Site 38
  • Guangdong
    • Guangzhou, Guangdong, China
      • Connect Investigative Site 07
    • Guangzhou, Guangdong, China
      • Connect Investigative Site 25
    • Guangzhou, Guangdong, China
      • Connect Investigative Site 37
    • Guangzhou, Guangdong, China
      • Connect Investigative Site 46
    • Guangzhou, Guangdong, China
      • Connect Investigative Site 48
    • Shaoguan, Guangdong, China
      • Connect Investigative Site 43
    • Shenzhen, Guangdong, China
      • Connect Investigative Site 52
  • Hainan
    • Haikou, Hainan, China
      • Connect Investigative Site 41
    • Haikou, Hainan, China
      • Connect Investigative Site 42
  • He'an
    • Zhengzhou, He'an, China
      • Connect Investigative Site 20
  • Hebei
    • Shijiazhuang, Hebei, China
      • Connect Investigative Site 32
  • Henan
    • Nanyang, Henan, China
      • Connect Investigative Site 45
    • Xinxiang, Henan, China
      • Connect Investigative Site 54
  • Hubei
    • Wuhan, Hubei, China
      • Connect Investigative Site 49
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Connect Investigative Site 35
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Connect Investigative Site 26
    • Suzhou, Jiangsu, China
      • Connect Investigative Site 18
    • Wuxi, Jiangsu, China
      • Connect Investigative Site 55
    • Zhenjiang, Jiangsu, China
      • Connect Investigative Site 10
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Connect Investigative Site 34
  • Ningxia
    • Yinchuan, Ningxia, China
      • Connect Investigative Site 44
  • Shandong
    • Jinan, Shandong, China
      • Connect Investigative Site 11
    • Jinan, Shandong, China
      • Connect Investigative Site 50
    • Jinan, Shandong, China
      • Connect Investigative Site 51
    • Yantai, Shandong, China
      • Connect Investigative Site 12
  • Shanxi
    • Taiyuan, Shanxi, China
      • Connect Investigative Site 08
    • Taiyuan, Shanxi, China
      • Connect Investigative Site 24
    • Yuncheng, Shanxi, China
      • Connect Investigative Site 39
  • Tianjin
    • Tianjin, Tianjin, China
      • Connect Investigative Site 05
    • Tianjin, Tianjin, China
      • Connect Investigative Site 06
  • Xi'an
    • Shanxi, Xi'an, China
      • Connect Investigative Site 13
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Connect Investigative Site 22
  • Yunnan
    • Qujing, Yunnan, China
      • Connect Investigative Site 53
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Connect Investigative Site 14
    • Hangzhou, Zhejiang, China
      • Connect Investigative Site 15
    • Hangzhou, Zhejiang, China
      • Connect Investigative Site 16
    • Jinhua, Zhejiang, China
      • Connect Investigative Site 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 12≤ age ≤75 years at the screening visit, male or female;

2. 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 screening, visit and:

   a) The subject has been suffering from the disease for more than 1 year at the time of screening, and according to the judgment of the investigator, the subject has had poor response to topical drugs such as corticosteroids, phosphodiesterase-4 (PDE-4) inhibitors or calcineurin inhibitors (TCI), or it is not medically suitable for the subject to receive topical drug treatment (e.g., there are important side effects or safety risks);

   Note: Poor response is defined as any of the following conditions:

   i. The patient has not achieved and maintained response or reached a low disease activity state (equivalent to IGA 0=asymptomatic to 2=mild) despite regular use of topical therapy during the 1 year before baseline; ii. The patient has received systemic treatment for AD despite regular use of topical therapy during the 1 year before baseline.

   b. At the screening and baseline visit, Investigator's Global Assessment (IGA) score ≥3 (according to the validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD™] scale, see Section 17.4 Appendix D), Eczema Area and Severity Index (EASI) score≥16 (see Section 17.5, Appendix E), and≥10% body surface area (BSA) of AD involvement(see Section 17.6, Appendix F); c. The average score of the maximum pruritus intensity in the Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 (see Section 17.1, Appendix A).

   Note: The baseline average score of maximum pruritus intensity in the PP-NRS will be calculated based on the average value of the maximum pruritus intensity in the PP-NRS score [daily score range 0-10] every day within 7 days before randomization. In these 7 days, the scores of at least 4 days are required for the calculation of the baseline average score. If the patient's reporting days are less than 4 days in the 7 days before the planned date of randomization, randomization should be postponed until the requirements are met, but it is not allowed to exceed the maximum screening period of 28 days.

3. Able and willing to use a stable dose of a mild emollient at the AD involvement area twice a day starting from at least 7 days before baseline and continue to use it during the study period (see Section 8.1.1.2 Emollients).

4. Female subjects of childbearing potential (FCBP) and male subjects who have not undergone vasectomy must take highly effective contraceptive measures during the entire study period, including the 8-week follow-up period after discontinuation of study drug. Postmenopausal women (determined by testing follicle stimulating hormone [FSH]) 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; iv. Exceptions are: a) 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; or b) surgical sterilization (e.g., hysterectomy, bilateral oophorectomy).

5. Subjects and/or their guardians have the ability to learn the study requirements and process, and voluntarily take part in the clinical trial and sign an informed consent form (ICF); note: for subjects ≥18 years: subjects voluntarily agree to take part in the study by themselves and sign ICF; for subjects aged 12-17 years: subjects and their guardians voluntarily agree to take part in the study, the guardians sign the ICF, and the subjects sign the informed assent form for minors by themselves.
6. Subjects and/or their guardians are willing and able to comply with study visits and related procedures.

Exclusion Criteria:

1. Patients who have received any of the following treatments:

   1. Treatment with dupilumab or any anti-IL-4Rα or IL-13 antibodies;
   2. Topical drugs for treatment of AD or have the potential to affect the assessment of AD, including but not limited to corticosteroids, PDE-4 inhibitors, Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, tacrolimus or pimecrolimus, or traditional Chinese medicine (TCM) or herbal medicine, etc. within 2 weeks before baseline;
   3. Have undergone bleaching baths ≥ twice within 2 weeks before baseline;
   4. Have begun to use prescription emollients or emollients containing additives (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) to treat AD from the screening period (if the subject has started using this kind of emollient before the screening visit, they can continue to use it at a stable dose; if the subject is intolerable to the emollients provided uniformly by the sponsor during the screeing period, he/she can change to emollient of this kind used previously, but it must be used at a stable dose for at least 7 days before baseline and during the study period);
   5. Treatment with systemic corticosteroids or other immunosuppressive/immunomodulating substances (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitors) due to AD or other diseases within 4 weeks before baseline (except for corticosteroid inhalers and nasal sprays);
   6. Treatment with systemic TCM or herbal treatment within 4 weeks before baseline (note: except for those for the treatment of diseases other than AD, which are necessary and will neither increase the risks of the subjects nor affect the assessment of the study in accordance with the medical judgements of the investigator and/or specialist physician);
   7. Treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light emitting device (LED) therapy within 4 weeks before baseline;
   8. Have used any investigational drug/treatment within 4 weeks before baseline or 5 drug half-lives, whichever is longer;
   9. Treatment with other biological agents (e.g., omalizumab) within 3 months before baseline or 5 drug half-lives (if known), whichever is longer;
   10. Have been vaccinated with live (attenuated) vaccine within 8 weeks before baseline;
   11. Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline;
   12. Treatment with allergen specific immunotherapy (SIT) within 6 months before baseline (except those who were already on stable-dose therapy before baseline).

   Eligibility criteria Inclusion criteria

   Patients must meet all of the following criterias to be enrolled into this study:

2. Patients who meet any of the following:

   1. History of hypersensitivity to L-histidine, trehalose or Tween 80;
   2. Other skin complications in addition to AD that may interfere with the study assessments;
   3. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC);
   4. History of malignant tumor within 5 years before screening, except for cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma;
   5. Active tuberculosis (TB) at the screening visit, latent tuberculosis or a history of non-tuberculous Mycobacterium infection

   Note:

   • Unless there is a clear specialist record proving that the patient 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 necessary, T-spot test may be used for auxiliary diagnosis of suspected tuberculosis patients; f. 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 RNA polymerase chain reaction; or serologically positive for human immunodeficiency virus (HIV) at the screening visit; g. Any of the following laboratory test abnormalities at the screening visit: i. Aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal (ULN), or total bilirubin > 1.5×ULN ii. Serum creatinine > 1.2×ULN iii. Hemoglobin < 8.5 g/dl (85.0 g/L) in male patients and < 8.0 g/dl (80.0 g/L) in female patients iv. White blood cell count <3.0×109/L or ≥14×109/L v. Platelet count <100×109/L h. Planning to undergo major surgical operations during the study period; i. Used systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, antigenic drugs, or antifungal drugs due to infection within 4 weeks before the baseline visit, or suffered from superficial skin infection (e.g., impetigo) within 2 weeks before baseline (after the infection subsides, the subjects can be rescreened); j. History of parasite infection (e.g., helminth) within 6 months before baseline; k. According to the investigator's judgment, there is a known or suspected history of immunosuppression within 6 months before baseline, including a history of invasive opportunistic infections, such as aspergillosis, coccidiosis, histoplasmosis, HIV, listeriosis, Pneumocystis or tuberculosis, even if the infection has subsided; or there is an abnormally frequently recurrent or persistent infection; l. History of alcohol or drug abuse within 2 years before the screening visit; m. Any other medical or psychological condition (including clinically significant laboratory test abnormalities, ECG parameters, etc.) at the screening visit, which, as judged by the investigator, may indicate new and/or insufficiently understood diseases, may put the patient at an unreasonable risk due to his/her participation in the clinical trial, may lead to unreliable results of the patient's participation, or may interfere with the study assessments. The specific reasons for patients excluded due to this criterion will be indicated in the study documents (medical records, eCRF, etc.).
3. Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBP-201 Dose; CBP-201 Dose subcutaneous (SC) injection	Drug: CBP-201; CBP-201 subcutaneous(SC) injection.
Placebo Comparator: Placebo; subcutaneous (SC) injection	Drug: Placebo; subcutaneous(SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment (IGA) (0-1)	The proportion of subjects whose IGA score is 0-1 and decreased by ≥2 points	Baseline to Week16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI-75	The proportion of subjects achieving EASI-75	Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS)	The proportion of subjects whose weekly average PP-NRS is decreased by ≥ 4 points	Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS)	The proportion of subjects whose weekly average PP-NRS is decreased by ≥ 3 points	Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS)	Absolute value and percentage changes in the weekly average PP-NRS	Baseline to Week16
EASI-90	The proportion of subjects achieving EASI-90	Baseline to Week16

Collaborators and Investigators

• Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
• Investigators: Study Director: Suzhou Connect, Suzhou Connect Biopharmaceuticals, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CBP-201-CN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No