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A Study Assessing the Efficacy and Safety of CBP-201

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: NCT04444752
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Suzhou Connect Biopharmaceuticals, Ltd.

Brief Summary:
This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Eczema area and severity index (EASI) percentage change (EASI-overall) [ Time Frame: From Baseline to Week 16 ]
    Percentage change in EASI


Secondary Outcome Measures :
  1. Number of participants with Adverse Events (AE) [ Time Frame: From Screen (Day-45) until end of study at Week 24 ]
    Safety will be assessed on basis of AEs reported.

  2. Pharmacokinetics (Steady-state trough PK profile) [ Time Frame: From Baseline to Week 24 ]
    Whole blood for plasma CBP-201 concentrations will be obtained and analyzed.

  3. Change in serum concentrations of IL-4 [ Time Frame: From Baseline to Week 24 ]
    Changes from Baseline will be summarized with descriptive statistics in serum levels of IL-4.

  4. Change in serum concentrations of IL-13 [ Time Frame: From Baseline to Week 24 ]
    Changes from Baseline will be summarized with descriptive statistics in serum levels of IL-13.

  5. Change in serum concentrations of IgE [ Time Frame: From Baseline to Week 24 ]
    Changes from Baseline will be summarized with descriptive statistics in serum levels of IgE.

  6. Change in whole blood eosinophil counts [ Time Frame: From Baseline to Week 24 ]
    Changes from Baseline will be summarized with descriptive statistics in whole blood eosinophil counts.

  7. Investigator's Global Assessment (IGA) [ Time Frame: At Week 16 ]
    Proportion of subjects with IGA 0-1 and a reduction of ≥2 points

  8. EASI-50 [ Time Frame: From Baseline at Week 16 ]
    Proportion of subjects achieving ≥ 50% reduction of EASI score

  9. EASI-75 [ Time Frame: From Baseline at Week 16 ]
    Proportion of subjects achieving ≥ 75% reduction of EASI score

  10. EASI-90 [ Time Frame: From Baseline at Week 16 ]
    Proportion of subjects achieving ≥ 90% reduction of EASI score

  11. Change in Peak Pruritus Numerical Rating Scale(PP-NRS) [ Time Frame: From Baseline to Week 16 ]
    Percent change from Baseline in weekly average of PP-NRS score to Week 16

  12. Number of AD flares [ Time Frame: From Baseline through Week 16 ]
    Number of AD flares from baseline through Week 16

  13. Number of days with AD flare [ Time Frame: From Baseline through Week 16 ]
    Number of days with AD flare through Week 16



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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

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): NCT04444752


Contacts
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Contact: Malinda Longphre, PhD +15105203361 mlongphre@connectpharm.com
Contact: Maryam Yaghini +14156106887 myaghini@connectpharm.com

Locations
Show Show 47 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: NCT04444752    
Other Study ID Numbers: CBP-201-WW001
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: June 2020
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
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