A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

Moderate-to-severe Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444752
• Other study ID #: CBP-201-WW001
• Status: Completed
• Phase: Phase 2
• Start date: July 17, 2020
• Est. completion date: September 22, 2021

Study information

• Verified date: July 2023
• Source: Suzhou Connect Biopharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult subjects with moderate to severe atopic dermatitis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: September 22, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-severe Atopic Dermatitis

Intervention

Drug:
• CBP-201
CBP-201 subcutaneous(SC) injection.
• placebo
subcutaneous(SC) injection

Locations

Country	Name	City	State
Australia	Connect Investigative Site 101	Brisbane	Queensland
Australia	Connect Investigative Site 111	Canberra	Australian Capital Territory
Australia	Connect Investigative Site 104	Darlinghurst	New South Wales
Australia	Connect Investigative Site 106	Fremantle	Western Australia
Australia	Connect Investigative Site 108	Kanwal	New South Wales
Australia	Connect Investigative Site 102	Melbourne	Victoria
Australia	Connect Investigative Site 103	Perth	Western Australia
Australia	Connect Investigative Site 105	Sydney	New South Wales
China	Connect Investigative Site 404	Beijing	Beijing
China	Connect Investigative Site 408	Beijing	Beijing
China	Connect Investigative Site 403	Hangzhou	Zhejiang
China	Connect Investigative Site 402	Jinan	Shandong
China	Connect Investigative Site 401	Shanghai	Shanghai
China	Connect Investigative Site 406	Shanghai	Shanghai
China	Connect Investigative Site 410	Tianjin	Tianjin
China	Connect Investigative Site 405	Wuxi	Jiangsu
China	Connect Investigative Site 409	Zhenjiang	Jiangsu
New Zealand	Connect Investigative Site 203	Auckland
New Zealand	Connect Investigative Site 202	Havelock North	Hawke's Bay
New Zealand	Connect Investigative Site 204	Tauranga	Bay Of Plenty
New Zealand	Connect Investigative Site 205	Waikanae	Kapiti Coast
United States	Connect Investigative Site 326	Albuquerque	New Mexico
United States	Connect Investigative Site 327	Canoga Park	California
United States	Connect Investigative Site 303	Chicago	Illinois
United States	Connect Investigative Site 333	Chicago	Illinois
United States	Connect Investigative Site 330	Cincinnati	Ohio
United States	Connect Investigative Site 332	Coral Gables	Florida
United States	Connect Investigative Site 324	Encinitas	California
United States	Connect Investigative Site 301	Fremont	California
United States	Connect Investigative Site 310	Glendale	Arizona
United States	Connect Investigative Site 320	Hialeah	Florida
United States	Connect Investigative Site 306	Hollywood	Florida
United States	Connect Investigative Site 334	Houston	Texas
United States	Connect Investigative Site 319	Hunt Valley	Maryland
United States	Connect Investigative Site 312	Huntington Beach	California
United States	Connect Investigative Site 308	Jacksonville	Florida
United States	Connect Investigative Site 336	Las Vegas	Nevada
United States	Connect Investigative Site 305	Little Rock	Arkansas
United States	Connect Investigative Site 311	Louisville	Kentucky
United States	Connect Investigative Site 314	Maitland	Florida
United States	Connect Investigative Site 309	Memphis	Tennessee
United States	Connect Investigative Site 321	Miami	Florida
United States	Connect Investigative Site 331	Miami	Florida
United States	Connect Investigative Site 337	Miami	Florida
United States	Connect Investigative Site 329	Mission Viejo	California
United States	Connect Investigative Site 307	New Albany	Indiana
United States	Connect Investigative Site 304	Orlando	Florida
United States	Connect Investigative Site 338	Phoenix	Arizona
United States	Connect Investigative Site 328	Rapid City	South Dakota
United States	Connect Investigative Site 335	Saint Joseph	Missouri
United States	Connect Investigative Site 315	Saint Louis	Missouri
United States	Connect Investigative Site 322	San Diego	California
United States	Connect Investigative Site 323	San Luis Obispo	California
United States	Connect Investigative Site 317	Santa Ana	California
United States	Connect Investigative Site 318	Sherman Oaks	California
United States	Connect Investigative Site 316	Tempe	Arizona
United States	Connect Investigative Site 325	Thousand Oaks	California
United States	Connect Investigative Site 313	West Lafayette	Indiana
United States	Connect Investigative Site 340	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Connect Biopharmaceuticals, Ltd.

Countries where clinical trial is conducted

United States,  Australia,  China,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Reduction in EASI Score From Baseline to Week 16	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	vIGA of 0/1 at Week 16	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