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

Phase 2

Completed

• Conditions: Moderate-to-severe Atopic Dermatitis
• Interventions: Drug: CBP-201; Drug: placebo

• Registration Number: NCT04444752
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-24
• Study Start: 2020-07-17
• Primary Completion: 2021-07-28
• Study Completion: 2021-09-22
• Results First Submitted: 2022-11-09
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Results First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBP-201 Dose 1	CBP-201	CBP-201 Dose 1 subcutaneous (SC) injection
CBP-201 Dose 2	CBP-201	CBP-201 Dose 2 subcutaneous (SC) injection
CBP-201 Dose 3	CBP-201	CBP-201 Dose 3 subcutaneous (SC) injection
placebo	placebo	subcutaneous (SC) injection

Primary Outcome Measures

Name	Time	Method
Percent Reduction in EASI Score From Baseline to Week 16	Reduction from baseline to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
vIGA of 0/1 at Week 16	Response Rate at 16 weeks	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.

Trial Locations

Locations (59)

Connect Investigative Site 318; 🇺🇸 Sherman Oaks, California, United States

Connect Investigative Site 323; 🇺🇸 San Luis Obispo, California, United States

Connect Investigative Site 332; 🇺🇸 Coral Gables, Florida, United States

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Connect Investigative Site 108; 🇦🇺 Kanwal, New South Wales, Australia

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Connect Investigative Site 102; 🇦🇺 Melbourne, Victoria, Australia

Connect Investigative Site 409; 🇨🇳 Zhenjiang, Jiangsu, China

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Connect Investigative Site 328; 🇺🇸 Rapid City, South Dakota, United States

Connect Investigative Site 101; 🇦🇺 Brisbane, Queensland, Australia

Connect Investigative Site 203; 🇳🇿 Auckland, New Zealand

Connect Investigative Site 303; 🇺🇸 Chicago, Illinois, United States

Connect Investigative Site 105; 🇦🇺 Sydney, New South Wales, Australia

Connect Investigative Site 104; 🇦🇺 Darlinghurst, New South Wales, Australia

Connect Investigative Site 404; 🇨🇳 Beijing, Beijing, China

Connect Investigative Site 205; 🇳🇿 Waikanae, Kapiti Coast, New Zealand

Connect Investigative Site 317; 🇺🇸 Santa Ana, California, United States

Connect Investigative Site 335; 🇺🇸 Saint Joseph, Missouri, United States

Connect Investigative Site 331; 🇺🇸 Miami, Florida, United States

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Connect Investigative Site 410; 🇨🇳 Tianjin, Tianjin, China

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Connect Investigative Site 403; 🇨🇳 Hangzhou, Zhejiang, China

Connect Investigative Site 106; 🇦🇺 Fremantle, Western Australia, Australia

Connect Investigative Site 103; 🇦🇺 Perth, Western Australia, Australia

Connect Investigative Site 111; 🇦🇺 Canberra, Australian Capital Territory, Australia

Connect Investigative Site 327; 🇺🇸 Canoga Park, California, United States

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Connect Investigative Site 329; 🇺🇸 Mission Viejo, California, United States

Connect Investigative Site 325; 🇺🇸 Thousand Oaks, California, United States

Connect Investigative Site 308; 🇺🇸 Jacksonville, Florida, United States

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Connect Investigative Site 319; 🇺🇸 Hunt Valley, Maryland, United States

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Connect Investigative Site 309; 🇺🇸 Memphis, Tennessee, United States

Connect Investigative Site 405; 🇨🇳 Wuxi, Jiangsu, China

Connect Investigative Site 402; 🇨🇳 Jinan, Shandong, China

Connect Investigative Site 202; 🇳🇿 Havelock North, Hawke's Bay, New Zealand

Connect Investigative Site 204; 🇳🇿 Tauranga, Bay Of Plenty, New Zealand

Connect Investigative Site 316; 🇺🇸 Tempe, Arizona, United States

Connect Investigative Site 338; 🇺🇸 Phoenix, Arizona, United States

Connect Investigative Site 304; 🇺🇸 Orlando, Florida, United States

Connect Investigative Site 311; 🇺🇸 Louisville, Kentucky, United States

Connect Investigative Site 326; 🇺🇸 Albuquerque, New Mexico, United States