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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04444752




Registration number
NCT04444752
Ethics application status
Date submitted
15/06/2020
Date registered
24/06/2020

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
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
Secondary ID [1] 0 0
CBP-201-WW001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-severe Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Reduction in EASI Score From Baseline to Week 16
Timepoint [1] 0 0
Reduction from baseline to 16 weeks
Secondary outcome [1] 0 0
vIGA of 0/1 at Week 16
Timepoint [1] 0 0
Response Rate at 16 weeks

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2021
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Connect Investigative Site 111 - Canberra
Recruitment hospital [2] 0 0
Connect Investigative Site 104 - Darlinghurst
Recruitment hospital [3] 0 0
Connect Investigative Site 108 - Kanwal
Recruitment hospital [4] 0 0
Connect Investigative Site 105 - Sydney
Recruitment hospital [5] 0 0
Connect Investigative Site 101 - Brisbane
Recruitment hospital [6] 0 0
Connect Investigative Site 102 - Melbourne
Recruitment hospital [7] 0 0
Connect Investigative Site 106 - Fremantle
Recruitment hospital [8] 0 0
Connect Investigative Site 103 - Perth
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2289 - Sydney
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Jiangsu
Country [18] 0 0
China
State/province [18] 0 0
Shandong
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
New Zealand
State/province [22] 0 0
Bay Of Plenty
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hawke's Bay
Country [24] 0 0
New Zealand
State/province [24] 0 0
Kapiti Coast
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Suzhou Connect Biopharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzhou Connect
Address 0 0
Suzhou Connect Biopharmaceuticals, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04444752