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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • 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
  • China
    • 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
  • New Zealand
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBP-201 Dose 1
CBP-201 Dose 1 subcutaneous (SC) injection
Drug: CBP-201
CBP-201 subcutaneous(SC) injection.
Experimental: CBP-201 Dose 2
CBP-201 Dose 2 subcutaneous (SC) injection
Drug: CBP-201
CBP-201 subcutaneous(SC) injection.
Experimental: CBP-201 Dose 3
CBP-201 Dose 3 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Connect Biopharmaceuticals, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBP-201-WW001

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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