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

A Study Assessing the Efficacy and Safety of CBP-201

Sponsors

Lead sponsor: Suzhou Connect Biopharmaceuticals, Ltd.

Source 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.

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.

Overall Status Recruiting
Start Date June 23, 2020
Completion Date March 31, 2022
Primary Completion Date September 30, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Eczema area and severity index (EASI) percentage change (EASI-overall) From Baseline to Week 16
Secondary Outcome
Measure Time Frame
Number of participants with Adverse Events (AE) From Screen (Day-45) until end of study at Week 24
Pharmacokinetics (Steady-state trough PK profile) From Baseline to Week 24
Change in serum concentrations of IL-4 From Baseline to Week 24
Change in serum concentrations of IL-13 From Baseline to Week 24
Change in serum concentrations of IgE From Baseline to Week 24
Change in whole blood eosinophil counts From Baseline to Week 24
Investigator's Global Assessment (IGA) At Week 16
EASI-50 From Baseline at Week 16
EASI-75 From Baseline at Week 16
EASI-90 From Baseline at Week 16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) From Baseline to Week 16
Number of AD flares From Baseline through Week 16
Number of days with AD flare From Baseline through Week 16
Enrollment 220
Condition
Intervention

Intervention type: Drug

Intervention name: CBP-201

Description: CBP-201 subcutaneous(SC) injection.

Intervention type: Drug

Intervention name: placebo

Description: subcutaneous(SC) injection

Arm group label: placebo

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Suzhou Connect Study Director Suzhou Connect Biopharmaceuticals, Ltd.
Overall Contact

Last name: Malinda Longphre, PhD

Phone: +15105203361

Email: [email protected]

Location
facility status
Connect Investigative Site 316 | Gilbert, Arizona, 85295, United States Not yet recruiting
Connect Investigative Site 310 | Glendale, Arizona, 85308, United States Not yet recruiting
Connect Investigative Site 305 | Little Rock, Arkansas, 72204, United States Not yet recruiting
Connect Investigative Site 301 | Fremont, California, 94538, United States Not yet recruiting
Connect Investigative Site 312 | Huntington Beach, California, 92647, United States Not yet recruiting
Connect Investigative Site 306 | Hollywood, Florida, 33021, United States Recruiting
Connect Investigative Site 308 | Jacksonville, Florida, 32256, United States Not yet recruiting
Connect Investigative Site 314 | Maitland, Florida, 32751, United States Not yet recruiting
Connect Investigative Site 304 | Orlando, Florida, 32801, United States Recruiting
Connect Investigative Site 303 | Chicago, Illinois, 60660, United States Not yet recruiting
Connect Investigative Site 307 | New Albany, Indiana, 47150, United States Not yet recruiting
Connect Investigative Site 313 | West Lafayette, Indiana, 47906, United States Not yet recruiting
Connect Investigative Site 311 | Louisville, Kentucky, 40241, United States Not yet recruiting
Connect Investigative Site 315 | Saint Louis, Missouri, 63110, United States Not yet recruiting
Connect Investigative Site 309 | Memphis, Tennessee, 38119, United States Not yet recruiting
Connect Investigative Site 302 | Lynchburg, Virginia, 24501, United States Not yet recruiting
Connect Investigative Site 110 | Bruce, Australian Capital Territory, 2617, Australia Not yet recruiting
Connect Investigative Site 107 | Blacktown, New South Wales, 2148, Australia Not yet recruiting
Connect Investigative Site 104 | Darlinghurst, New South Wales, 2010, Australia Not yet recruiting
Connect Investigative Site 108 | Kanwal, New South Wales, 2259, Australia Not yet recruiting
Connect Investigative Site 105 | Kotara, New South Wales, 2289, Australia Not yet recruiting
Connect Investigative Site 102 | Melbourne, Victoria, 3002, Australia Not yet recruiting
Connect Investigative Site 106 | Fremantle, Western Australia, 6060, Australia Not yet recruiting
Connect Investigative Site 103 | Nedlands, Western Australia, 6009, Australia Not yet recruiting
Connect Investigative Site 401 | Shanghai, 200040, China Not yet recruiting
Connect Investigative Site 203 | Auckland, 1010, New Zealand Not yet recruiting
Connect Investigative Site 202 | Havelock North, 4130, New Zealand Not yet recruiting
Connect Investigative Site 204 | Tauranga, 3112, New Zealand Not yet recruiting
Location Countries

Australia

China

New Zealand

United States

Verification Date

June 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: CBP-201 Dose 1

Arm group type: Experimental

Description: CBP-201 Dose 1 subcutaneous (SC) injection

Arm group label: CBP-201 Dose 2

Arm group type: Experimental

Description: CBP-201 Dose 2 subcutaneous (SC) injection

Arm group label: CBP-201 Dose 3

Arm group type: Experimental

Description: CBP-201 Dose 3 subcutaneous (SC) injection

Arm group label: placebo

Arm group type: Placebo Comparator

Description: subcutaneous (SC) injection

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov