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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04444752
Registration number
NCT04444752
Ethics application status
Date submitted
15/06/2020
Date registered
24/06/2020
Date last updated
1/08/2023
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
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Scientific 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
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Secondary ID [1]
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CBP-201-WW001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderate-to-severe Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CBP-201
Treatment: Drugs - placebo
Experimental: CBP-201 Dose 1 - CBP-201 Dose 1 subcutaneous (SC) injection
Experimental: CBP-201 Dose 2 - CBP-201 Dose 2 subcutaneous (SC) injection
Experimental: CBP-201 Dose 3 - CBP-201 Dose 3 subcutaneous (SC) injection
Placebo Comparator: placebo - subcutaneous (SC) injection
Treatment: Drugs: CBP-201
CBP-201 subcutaneous(SC) injection.
Treatment: Drugs: placebo
subcutaneous(SC) injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Reduction in EASI Score From Baseline to Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Reduction from baseline to 16 weeks
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Secondary outcome [1]
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vIGA of 0/1 at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Response Rate at 16 weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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-4Ra 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/09/2021
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Sample size
Target
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Connect Investigative Site 111 - Canberra
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Recruitment hospital [2]
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Connect Investigative Site 104 - Darlinghurst
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Recruitment hospital [3]
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Connect Investigative Site 108 - Kanwal
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Recruitment hospital [4]
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Connect Investigative Site 105 - Sydney
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Recruitment hospital [5]
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Connect Investigative Site 101 - Brisbane
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Recruitment hospital [6]
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Connect Investigative Site 102 - Melbourne
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Recruitment hospital [7]
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Connect Investigative Site 106 - Fremantle
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Recruitment hospital [8]
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Connect Investigative Site 103 - Perth
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Recruitment postcode(s) [1]
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2606 - Canberra
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2259 - Kanwal
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Recruitment postcode(s) [4]
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2289 - Sydney
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Recruitment postcode(s) [5]
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4102 - Brisbane
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Recruitment postcode(s) [6]
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3002 - Melbourne
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Recruitment postcode(s) [7]
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6160 - Fremantle
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Recruitment postcode(s) [8]
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6009 - Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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Arkansas
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California
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Florida
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Illinois
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Indiana
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Kentucky
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Maryland
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Missouri
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Texas
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China
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Beijing
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China
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Jiangsu
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China
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Shandong
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China
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Shanghai
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China
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Tianjin
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China
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Zhejiang
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New Zealand
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Bay Of Plenty
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New Zealand
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Hawke's Bay
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New Zealand
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Kapiti Coast
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New Zealand
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Suzhou Connect Biopharmaceuticals, Ltd.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
CBP-201 in adult subjects with moderate to severe atopic dermatitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04444752
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Suzhou Connect
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Address
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Suzhou Connect Biopharmaceuticals, Ltd.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04444752
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