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

NCT04444752 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CBP-201-WW001
• Study Type: interventional
• Target: 226
• Locations: 4 countries
• Sites: 59

Brief Summary

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

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• vIGA of 0/1 at Week 16

  Response Rate at 16 weeks

Study Arms (4)

CBP-201 Dose 1

EXPERIMENTAL

CBP-201 Dose 1 subcutaneous (SC) injection

Drug: CBP-201

CBP-201 Dose 2

EXPERIMENTAL

CBP-201 Dose 2 subcutaneous (SC) injection

Drug: CBP-201

CBP-201 Dose 3

EXPERIMENTAL

CBP-201 Dose 3 subcutaneous (SC) injection

Drug: CBP-201

placebo

PLACEBO COMPARATOR

subcutaneous (SC) injection

Drug: placebo

Interventions

CBP-201 DRUG

CBP-201 subcutaneous(SC) injection.

CBP-201 Dose 1; CBP-201 Dose 2; CBP-201 Dose 3

placebo DRUG

subcutaneous(SC) injection

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)
• Investigator Global Assessment (IGA) score ≥ 3 at Screening and Baseline.
• Eczema Area and Severity Index (EASI) score ≥ 16 at Screening and Baseline
• Body Surface Area (BSA) for total AD involvement ≥ 10% at Screening and Baseline
• 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
• 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.

You may not qualify if:

• Have any of the following laboratory abnormalities at Screening:
• Hemoglobin ≤ 90% of the lower limit of normal range (LLN)
• White blood cell (WBC) below the LLN
• Neutrophil count below the LLN
• Platelet count below the LLN
• Have undergone treatment with any of the following:
• 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
• Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13
• 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.
• 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
• 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
• ≥ 2 bleach baths within 2 weeks of Baseline
• Prescription emollient to treat AD (e.g. Atopiclair®, MimyX®, Epicerum®, etc.) within 2 weeks of Baseline
• Any investigational drug within 30 days or within 5 half-lives, whichever is longer, before Baseline.
• Live (attenuated) vaccine within 8 weeks of Baseline.

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (59)

Connect Investigative Site 310

Glendale, Arizona, 85308, United States

Location

Connect Investigative Site 338

Phoenix, Arizona, 85001, United States

Location

Connect Investigative Site 316

Tempe, Arizona, 85284, United States

Location

Connect Investigative Site 305

Little Rock, Arkansas, 72204, United States

Location

Connect Investigative Site 327

Canoga Park, California, 91303, United States

Location

Connect Investigative Site 324

Encinitas, California, 92024, United States

Location

Connect Investigative Site 301

Fremont, California, 94538, United States

Location

Connect Investigative Site 312

Huntington Beach, California, 92647, United States

Location

Connect Investigative Site 329

Mission Viejo, California, 92691, United States

Location

Connect Investigative Site 322

San Diego, California, 92123, United States

Location

Connect Investigative Site 323

San Luis Obispo, California, 93405, United States

Location

Connect Investigative Site 317

Santa Ana, California, 92703, United States

Location

Connect Investigative Site 318

Sherman Oaks, California, 91403, United States

Location

Connect Investigative Site 325

Thousand Oaks, California, 91320, United States

Location

Connect Investigative Site 332

Coral Gables, Florida, 33144, United States

Location

Connect Investigative Site 320

Hialeah, Florida, 33016, United States

Location

Connect Investigative Site 306

Hollywood, Florida, 33021, United States

Location

Connect Investigative Site 308

Jacksonville, Florida, 32256, United States

Location

Connect Investigative Site 314

Maitland, Florida, 32751, United States

Location

Connect Investigative Site 331

Miami, Florida, 33155, United States

Location

Connect Investigative Site 337

Miami, Florida, 33155, United States

Location

Connect Investigative Site 321

Miami, Florida, 33173, United States

Location

Connect Investigative Site 304

Orlando, Florida, 32801, United States

Location

Connect Investigative Site 340

Weston, Florida, 33331, United States

Location

Connect Investigative Site 333

Chicago, Illinois, 60640, United States

Location

Connect Investigative Site 303

Chicago, Illinois, 60660, United States

Location

Connect Investigative Site 307

New Albany, Indiana, 47150, United States

Location

Connect Investigative Site 313

West Lafayette, Indiana, 47906, United States

Location

Connect Investigative Site 311

Louisville, Kentucky, 40241, United States

Location

Connect Investigative Site 319

Hunt Valley, Maryland, 21030, United States

Location

Connect Investigative Site 335

Saint Joseph, Missouri, 64506, United States

Location

Connect Investigative Site 315

St Louis, Missouri, 63110, United States

Location

Connect Investigative Site 336

Las Vegas, Nevada, 89109, United States

Location

Connect Investigative Site 326

Albuquerque, New Mexico, 87102, United States

Location

Connect Investigative Site 330

Cincinnati, Ohio, 45231, United States

Location

Connect Investigative Site 328

Rapid City, South Dakota, 57702, United States

Location

Connect Investigative Site 309

Memphis, Tennessee, 38119, United States

Location

Connect Investigative Site 334

Houston, Texas, 77065, United States

Location

Connect Investigative Site 111

Canberra, Australian Capital Territory, 2606, Australia

Location

Connect Investigative Site 104

Darlinghurst, New South Wales, 2010, Australia

Location

Connect Investigative Site 108

Kanwal, New South Wales, 2259, Australia

Location

Connect Investigative Site 105

Sydney, New South Wales, 2289, Australia

Location

Connect Investigative Site 101

Brisbane, Queensland, 4102, Australia

Location

Connect Investigative Site 102

Melbourne, Victoria, 3002, Australia

Location

Connect Investigative Site 106

Fremantle, Western Australia, 6160, Australia

Location

Connect Investigative Site 103

Perth, Western Australia, 6009, Australia

Location

Connect Investigative Site 408

Beijing, Beijing Municipality, 100020, China

Location

Connect Investigative Site 404

Beijing, Beijing Municipality, 100050, China

Location

Connect Investigative Site 405

Wuxi, Jiangsu, 214002, China

Location

Connect Investigative Site 409

Zhenjiang, Jiangsu, 212001, China

Location

Connect Investigative Site 402

Jinan, Shandong, 250013, China

Location

Connect Investigative Site 401

Shanghai, Shanghai Municipality, 200040, China

Location

Connect Investigative Site 406

Shanghai, Shanghai Municipality, 200071, China

Location

Connect Investigative Site 410

Tianjin, Tianjin Municipality, 300120, China

Location

Connect Investigative Site 403

Hangzhou, Zhejiang, 310003, China

Location

Connect Investigative Site 204

Tauranga, Bay of Plenty, 3110, New Zealand

Location

Connect Investigative Site 202

Havelock North, Hawke's Bay Region, 4130, New Zealand

Location

Connect Investigative Site 205

Waikanae, Kapiti Coast, 5036, New Zealand

Location

Connect Investigative Site 203

Auckland, 1010, New Zealand

Location

Results Point of Contact

• Title: Malinda Longphre
• Organization: Head of Clinical Operations US

Mlongphre@connectpharm.com

+15105203361

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 24, 2020
• Study Start: July 17, 2020
• Primary Completion: July 28, 2021
• Study Completion: September 22, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4); CN (9); US (38); AU (8)