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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04444752
Ethics application status
Date submitted
15/06/2020
Date registered
24/06/2020
Date last updated
5/11/2020

Titles & IDs
Public title
A Study Assessing the Efficacy and Safety of CBP-201
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
Eczema area and severity index (EASI) percentage change (EASI-overall) - Percentage change in EASI
Timepoint [1] 0 0
From Baseline to Week 16
Secondary outcome [1] 0 0
Number of participants with Adverse Events (AE) - Safety will be assessed on basis of AEs reported.
Timepoint [1] 0 0
From Screen (Day-45) until end of study at Week 24
Secondary outcome [2] 0 0
Pharmacokinetics (Steady-state trough PK profile) - Whole blood for plasma CBP-201 concentrations will be obtained and analyzed.
Timepoint [2] 0 0
From Baseline to Week 24
Secondary outcome [3] 0 0
Change in serum concentrations of IL-4 - Changes from Baseline will be summarized with descriptive statistics in serum levels of IL-4.
Timepoint [3] 0 0
From Baseline to Week 24
Secondary outcome [4] 0 0
Change in serum concentrations of IL-13 - Changes from Baseline will be summarized with descriptive statistics in serum levels of IL-13.
Timepoint [4] 0 0
From Baseline to Week 24
Secondary outcome [5] 0 0
Change in serum concentrations of IgE - Changes from Baseline will be summarized with descriptive statistics in serum levels of IgE.
Timepoint [5] 0 0
From Baseline to Week 24
Secondary outcome [6] 0 0
Change in whole blood eosinophil counts - Changes from Baseline will be summarized with descriptive statistics in whole blood eosinophil counts.
Timepoint [6] 0 0
From Baseline to Week 24
Secondary outcome [7] 0 0
Investigator's Global Assessment (IGA) - Proportion of subjects with IGA 0-1 and a reduction of =2 points
Timepoint [7] 0 0
At Week 16
Secondary outcome [8] 0 0
EASI-50 - Proportion of subjects achieving = 50% reduction of EASI score
Timepoint [8] 0 0
From Baseline at Week 16
Secondary outcome [9] 0 0
EASI-75 - Proportion of subjects achieving = 75% reduction of EASI score
Timepoint [9] 0 0
From Baseline at Week 16
Secondary outcome [10] 0 0
EASI-90 - Proportion of subjects achieving = 90% reduction of EASI score
Timepoint [10] 0 0
From Baseline at Week 16
Secondary outcome [11] 0 0
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) - Percent change from Baseline in weekly average of PP-NRS score to Week 16
Timepoint [11] 0 0
From Baseline to Week 16
Secondary outcome [12] 0 0
Number of AD flares - Number of AD flares from baseline through Week 16
Timepoint [12] 0 0
From Baseline through Week 16
Secondary outcome [13] 0 0
Number of days with AD flare - Number of days with AD flare through Week 16
Timepoint [13] 0 0
From Baseline through Week 16

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 108 - Kanwal
Recruitment hospital [3] 0 0
Connect Investigative Site 105 - Sydney
Recruitment hospital [4] 0 0
Connect Investigative Site 101 - Brisbane
Recruitment hospital [5] 0 0
Connect Investigative Site 102 - Melbourne
Recruitment hospital [6] 0 0
Connect Investigative Site 106 - Fremantle
Recruitment hospital [7] 0 0
Connect Investigative Site 103 - Perth
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2289 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment postcode(s) [7] 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
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Shandong
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
China
State/province [22] 0 0
Tianjin
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
New Zealand
State/province [24] 0 0
Bay Of Plenty
Country [25] 0 0
New Zealand
State/province [25] 0 0
Hawke's Bay
Country [26] 0 0
New Zealand
State/province [26] 0 0
Kapiti Coast
Country [27] 0 0
New Zealand
State/province [27] 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
This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
CBP-201 in adult subjects with moderate to severe atopic dermatitis.
Trial website
https://clinicaltrials.gov/show/NCT04444752
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
Malinda Longphre, PhD
Address 0 0
Country 0 0
Phone 0 0
+15105203361
Fax 0 0
Email 0 0
mlongphre@connectpharm.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04444752