A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

July 31, 2023 updated by: Suzhou Connect Biopharmaceuticals, Ltd.

A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 16 weeks and a follow-up period of 8 weeks.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2606
        • Connect Investigative Site 111
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Connect Investigative Site 104
      • Kanwal, New South Wales, Australia, 2259
        • Connect Investigative Site 108
      • Sydney, New South Wales, Australia, 2289
        • Connect Investigative Site 105
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Connect Investigative Site 101
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Connect Investigative Site 102
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Connect Investigative Site 106
      • Perth, Western Australia, Australia, 6009
        • Connect Investigative Site 103
    • Beijing
      • Beijing, Beijing, China, 100020
        • Connect Investigative Site 408
      • Beijing, Beijing, China, 100050
        • Connect Investigative Site 404
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Connect Investigative Site 405
      • Zhenjiang, Jiangsu, China, 212001
        • Connect Investigative Site 409
    • Shandong
      • Jinan, Shandong, China, 250013
        • Connect Investigative Site 402
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Connect Investigative Site 401
      • Shanghai, Shanghai, China, 200071
        • Connect Investigative Site 406
    • Tianjin
      • Tianjin, Tianjin, China, 300120
        • Connect Investigative Site 410
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Connect Investigative Site 403
      • Auckland, New Zealand, 1010
        • Connect Investigative Site 203
    • Bay Of Plenty
      • Tauranga, Bay Of Plenty, New Zealand, 3110
        • Connect Investigative Site 204
    • Hawke's Bay
      • Havelock North, Hawke's Bay, New Zealand, 4130
        • Connect Investigative Site 202
    • Kapiti Coast
      • Waikanae, Kapiti Coast, New Zealand, 5036
        • Connect Investigative Site 205
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Connect Investigative Site 310
      • Phoenix, Arizona, United States, 85001
        • Connect Investigative Site 338
      • Tempe, Arizona, United States, 85284
        • Connect Investigative Site 316
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Connect Investigative Site 305
    • California
      • Canoga Park, California, United States, 91303
        • Connect Investigative Site 327
      • Encinitas, California, United States, 92024
        • Connect Investigative Site 324
      • Fremont, California, United States, 94538
        • Connect Investigative Site 301
      • Huntington Beach, California, United States, 92647
        • Connect Investigative Site 312
      • Mission Viejo, California, United States, 92691
        • Connect Investigative Site 329
      • San Diego, California, United States, 92123
        • Connect Investigative Site 322
      • San Luis Obispo, California, United States, 93405
        • Connect Investigative Site 323
      • Santa Ana, California, United States, 92703
        • Connect Investigative Site 317
      • Sherman Oaks, California, United States, 91403
        • Connect Investigative Site 318
      • Thousand Oaks, California, United States, 91320
        • Connect Investigative Site 325
    • Florida
      • Coral Gables, Florida, United States, 33144
        • Connect Investigative Site 332
      • Hialeah, Florida, United States, 33016
        • Connect Investigative Site 320
      • Hollywood, Florida, United States, 33021
        • Connect Investigative Site 306
      • Jacksonville, Florida, United States, 32256
        • Connect Investigative Site 308
      • Maitland, Florida, United States, 32751
        • Connect Investigative Site 314
      • Miami, Florida, United States, 33155
        • Connect Investigative Site 331
      • Miami, Florida, United States, 33155
        • Connect Investigative Site 337
      • Miami, Florida, United States, 33173
        • Connect Investigative Site 321
      • Orlando, Florida, United States, 32801
        • Connect Investigative Site 304
      • Weston, Florida, United States, 33331
        • Connect Investigative Site 340
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Connect Investigative Site 333
      • Chicago, Illinois, United States, 60660
        • Connect Investigative Site 303
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Connect Investigative Site 307
      • West Lafayette, Indiana, United States, 47906
        • Connect Investigative Site 313
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Connect Investigative Site 311
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Connect Investigative Site 319
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Connect Investigative Site 335
      • Saint Louis, Missouri, United States, 63110
        • Connect Investigative Site 315
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Connect Investigative Site 336
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Connect Investigative Site 326
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Connect Investigative Site 330
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Connect Investigative Site 328
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Connect Investigative Site 309
    • Texas
      • Houston, Texas, United States, 77065
        • Connect Investigative Site 334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be an adult ≥18 and ≤ 75 years of age at the screening visit (Screening) with atopic dermatitis according to American Academy of Dermatology Consensus Criteria, (Eichenfield 2014)
  2. Present for at least 1 year prior to the baseline visit (Baseline) with an inadequate response, in the judgement of the Investigator, to AD treatment with a topical regimen of corticosteroids, phosphodiesterase inhibitors or calcineurin inhibitors, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effect or safety risks)
  3. Investigator Global Assessment (IGA) score ≥ 3 at Screening and Baseline.
  4. Eczema Area and Severity Index (EASI) score ≥ 16 at Screening and Baseline
  5. Body Surface Area (BSA) for total AD involvement ≥ 10% at Screening and Baseline
  6. Able and willing to apply a stable dose of a bland emollient twice a day to affected areas for at least 7 days before Baseline and to continue for the duration of the study
  7. Females of child-bearing potential (FCBP) and males who have not undergone a vasectomy must abstain from heterosexual activities or agree to use effective contraception throughout the entire study period.

Exclusion Criteria:

  1. Have any of the following laboratory abnormalities at Screening:

    1. Hemoglobin ≤ 90% of the lower limit of normal range (LLN)
    2. White blood cell (WBC) below the LLN
    3. Neutrophil count below the LLN
    4. Platelet count below the LLN
  2. Have undergone treatment with any of the following:

    1. Topical agents such as corticosteroids, phosphodiesterase (PDE) inhibitors, Janus kinase (JAK) inhibitors, tacrolimus or pimecrolimus within 1 week prior to Baseline. Note that low to medium potency topical corticosteroids (TCS) are permitted after randomization to treat AD flares
    2. Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13
    3. Systemic treatment for AD or other condition with steroids or other immunosuppressive/immunomodulating substances, e.g., cyclosporine, mycophenolate-mofetil, azathioprine, methotrexate or oral Janus kinase (JAK) inhibitors within 4 weeks prior to Baseline. Use of steroid inhalers and nasal corticosteroids is allowed.
    4. Cell depleting agents, e.g. rituximab, within 6 months of Baseline or treatment with other biologics within 5 half-lives (if known) or 3 months prior to baseline visit, whichever is longer
    5. Phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), tanning beds, or any other light emitting device (LED), within 4 weeks of Baseline
    6. ≥ 2 bleach baths within 2 weeks of Baseline
    7. Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.) within 2 weeks of Baseline
    8. Any investigational drug within 30 days or within 5 half-lives, whichever is longer, before Baseline.
    9. Live (attenuated) vaccine within 8 weeks of Baseline.
    10. Treatment with systemic traditional Chinese medicine (TCM) or herbal medications within 4 weeks before Baseline or treatment with topical TCM or herbal medications within 1 week before Baseline visit
  3. Have any of the following:

    1. Infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline, or superficial skin infection, such as impetigo, within 2 weeks before the Baseline (subjects may be rescreened after the infection has resolved)
    2. A history of parasitic infection (e.g. helminth), within 6 months of Baseline
    3. Per investigator judgement, known or suspected history of immunosuppression within 6 months of Baseline, including a history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, human immunodeficiency virus (HIV), listeriosis, pneumocystosis, or tuberculosis, despite infection resolution; or unusually frequent, recurrent or prolonged infections.
    4. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC)
    5. A history of malignancy with the following exceptions: completely treated carcinoma in situ of cervix or non-metastatic squamous or basal cell carcinoma of the skin
    6. Positive results at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody with positive HCV RNA polymerase chain reaction; positive HIV serology at screening
    7. An allergy to L-histidine, trehalose or Tween (polysorbate) 80
  4. Women must not be pregnant, planning to become pregnant or breast-feed during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBP-201 Dose 1
CBP-201 Dose 1 subcutaneous (SC) injection
CBP-201 subcutaneous(SC) injection.
Experimental: CBP-201 Dose 2
CBP-201 Dose 2 subcutaneous (SC) injection
CBP-201 subcutaneous(SC) injection.
Experimental: CBP-201 Dose 3
CBP-201 Dose 3 subcutaneous (SC) injection
CBP-201 subcutaneous(SC) injection.
Placebo Comparator: placebo
subcutaneous (SC) injection
subcutaneous(SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Reduction in EASI Score From Baseline to Week 16
Time Frame: Reduction from baseline to 16 weeks
EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.
Reduction from baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vIGA of 0/1 at Week 16
Time Frame: Response Rate at 16 weeks
Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.
Response Rate at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2020

Primary Completion (Actual)

July 28, 2021

Study Completion (Actual)

September 22, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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