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

NCT ID: NCT04444752

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-09-22

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.

Conditions

Moderate-to-severe Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CBP-201 Dose 1

CBP-201 Dose 1 subcutaneous (SC) injection

Group Type: EXPERIMENTAL

CBP-201

Intervention Type: DRUG

CBP-201 subcutaneous(SC) injection.

CBP-201 Dose 2

CBP-201 Dose 2 subcutaneous (SC) injection

Group Type: EXPERIMENTAL

CBP-201

Intervention Type: DRUG

CBP-201 subcutaneous(SC) injection.

CBP-201 Dose 3

CBP-201 Dose 3 subcutaneous (SC) injection

Group Type: EXPERIMENTAL

CBP-201

Intervention Type: DRUG

CBP-201 subcutaneous(SC) injection.

placebo

subcutaneous (SC) injection

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

subcutaneous(SC) injection

Interventions

CBP-201

CBP-201 subcutaneous(SC) injection.

Intervention Type: DRUG

placebo

subcutaneous(SC) injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connect Biopharm LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzhou Connect

Role: STUDY_DIRECTOR

Connect Biopharm LLC

Locations

Connect Investigative Site 310

Glendale, Arizona, United States

Connect Investigative Site 338

Phoenix, Arizona, United States

Connect Investigative Site 316

Tempe, Arizona, United States

Connect Investigative Site 305

Little Rock, Arkansas, United States

Connect Investigative Site 327

Canoga Park, California, United States

Connect Investigative Site 324

Encinitas, California, United States

Connect Investigative Site 301

Fremont, California, United States

Connect Investigative Site 312

Huntington Beach, California, United States

Connect Investigative Site 329

Mission Viejo, California, 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 325

Thousand Oaks, California, United States

Connect Investigative Site 332

Coral Gables, Florida, United States

Connect Investigative Site 320

Hialeah, Florida, United States

Connect Investigative Site 306

Hollywood, Florida, United States

Connect Investigative Site 308

Jacksonville, Florida, United States

Connect Investigative Site 314

Maitland, Florida, United States

Connect Investigative Site 331

Miami, Florida, United States

Connect Investigative Site 337

Miami, Florida, United States

Connect Investigative Site 321

Miami, Florida, United States

Connect Investigative Site 304

Orlando, Florida, United States

Connect Investigative Site 340

Weston, Florida, United States

Connect Investigative Site 333

Chicago, Illinois, United States

Connect Investigative Site 303

Chicago, Illinois, United States

Connect Investigative Site 307

New Albany, Indiana, United States

Connect Investigative Site 313

West Lafayette, Indiana, United States

Connect Investigative Site 311

Louisville, Kentucky, United States

Connect Investigative Site 319

Hunt Valley, Maryland, United States

Connect Investigative Site 335

Saint Joseph, Missouri, United States

Connect Investigative Site 315

St Louis, Missouri, United States

Connect Investigative Site 336

Las Vegas, Nevada, United States

Connect Investigative Site 326

Albuquerque, New Mexico, United States

Connect Investigative Site 330

Cincinnati, Ohio, United States

Connect Investigative Site 328

Rapid City, South Dakota, United States

Connect Investigative Site 309

Memphis, Tennessee, United States

Connect Investigative Site 334

Houston, Texas, United States

Connect Investigative Site 111

Canberra, Australian Capital Territory, Australia

Connect Investigative Site 104

Darlinghurst, New South Wales, Australia

Connect Investigative Site 108

Kanwal, New South Wales, Australia

Connect Investigative Site 105

Sydney, New South Wales, Australia

Connect Investigative Site 101

Brisbane, Queensland, Australia

Connect Investigative Site 102

Melbourne, Victoria, Australia

Connect Investigative Site 106

Fremantle, Western Australia, Australia

Connect Investigative Site 103

Perth, Western Australia, Australia

Connect Investigative Site 408

Beijing, Beijing Municipality, China

Connect Investigative Site 404

Beijing, Beijing Municipality, China

Connect Investigative Site 405

Wuxi, Jiangsu, China

Connect Investigative Site 409

Zhenjiang, Jiangsu, China

Connect Investigative Site 402

Jinan, Shandong, China

Connect Investigative Site 401

Shanghai, Shanghai Municipality, China

Connect Investigative Site 406

Shanghai, Shanghai Municipality, China

Connect Investigative Site 410

Tianjin, Tianjin Municipality, China

Connect Investigative Site 403

Hangzhou, Zhejiang, China

Connect Investigative Site 204

Tauranga, Bay of Plenty, New Zealand

Connect Investigative Site 202

Havelock North, Hawke's Bay Region, New Zealand

Connect Investigative Site 205

Waikanae, Kapiti Coast, New Zealand

Connect Investigative Site 203

Auckland, , New Zealand

Countries

United States; Australia; China; New Zealand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CBP-201-WW001

Identifier Type: -

Identifier Source: org_study_id