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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05017480
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Connect Biopharmaceuticals, Ltd.

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

Condition or disease Intervention/treatment Phase
Moderate-to-severe Atopic Dermatitis Drug: CBP-201 Drug: Placebo Phase 2

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 adult 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Multi-center, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of CBP-201 in Chinese Adult Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) (0-1) [ Time Frame: Baseline to Week16 ]
    The proportion of subjects whose IGA score is 0-1 and decreased by ≥2 points


Secondary Outcome Measures :
  1. EASI-75 [ Time Frame: Baseline to Week16 ]
    The proportion of subjects achieving EASI-75

  2. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) [ Time Frame: Baseline to Week16 ]
    The proportion of subjects whose weekly average PP-NRS is decreased by ≥ 4 points

  3. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) [ Time Frame: Baseline to Week16 ]
    The proportion of subjects whose weekly average PP-NRS is decreased by ≥ 3 points

  4. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) [ Time Frame: Baseline to Week16 ]
    Absolute value and percentage changes in the weekly average PP-NRS

  5. EASI-90 [ Time Frame: Baseline to Week16 ]
    The proportion of subjects achieving EASI-90



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18≤ 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 (PDE) 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. Able to read and understand, and voluntarily sign an informed consent form (ICF).
  6. 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. Treatment with topical drugs such as corticosteroids, PDE inhibitors, Janus kinase (JAK) inhibitors, tacrolimus or pimecrolimus, or traditional Chinese medicine (TCM) or herbal medicine within 2 weeks before baseline;
    3. Have undergone bleaching baths ≥ twice within 2 weeks before baseline;
    4. Have begun to use prescription moisturizers or moisturizers 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 moisturizer before the screening visit, they can continue to use it at a stable dose);
    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;
    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);
    6. 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;
    7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017480


Contacts
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Contact: John Guo +86-18118451571 jwguo@connectpharm.com
Contact: Jolan Zhao +86-16630676613 lzhao@connectpharm.com

Locations
Show Show 56 study locations
Sponsors and Collaborators
Suzhou Connect Biopharmaceuticals, Ltd.
Investigators
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Study Director: Suzhou Connect Suzhou Connect Biopharmaceuticals, Ltd.
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Responsible Party: Suzhou Connect Biopharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT05017480    
Other Study ID Numbers: CBP-201-CN002
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases