Clinical trial NCT04444752: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Lead sponsor: Connect Biopharm LLC
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Reduction in EASI Score From Baseline to Week 16
timeFrame: Reduction from baseline to 16 weeks
Secondary outcomes:
measure: vIGA of 0/1 at Week 16
timeFrame: Response Rate at 16 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Connect Investigative Site 310
state: Arizona
city: Phoenix
country: United States
facility: Connect Investigative Site 338
state: Arizona
city: Tempe
country: United States
facility: Connect Investigative Site 316
state: Arizona
city: Little Rock
country: United States
facility: Connect Investigative Site 305
state: Arkansas
city: Canoga Park
country: United States
facility: Connect Investigative Site 327
state: California
city: Encinitas
country: United States
facility: Connect Investigative Site 324
state: California
city: Fremont
country: United States
facility: Connect Investigative Site 301
state: California
city: Huntington Beach
country: United States
facility: Connect Investigative Site 312
state: California
city: Mission Viejo
country: United States
facility: Connect Investigative Site 329
state: California
city: San Diego
country: United States
facility: Connect Investigative Site 322
state: California
city: San Luis Obispo
country: United States
facility: Connect Investigative Site 323
state: California
city: Santa Ana
country: United States
facility: Connect Investigative Site 317
state: California
city: Sherman Oaks
country: United States
facility: Connect Investigative Site 318
state: California
city: Thousand Oaks
country: United States
facility: Connect Investigative Site 325
state: California
city: Coral Gables
country: United States
facility: Connect Investigative Site 332
state: Florida
city: Hialeah
country: United States
facility: Connect Investigative Site 320
state: Florida
city: Hollywood
country: United States
facility: Connect Investigative Site 306
state: Florida
city: Jacksonville
country: United States
facility: Connect Investigative Site 308
state: Florida
city: Maitland
country: United States
facility: Connect Investigative Site 314
state: Florida
city: Miami
country: United States
facility: Connect Investigative Site 331
state: Florida
city: Miami
country: United States
facility: Connect Investigative Site 337
state: Florida
city: Miami
country: United States
facility: Connect Investigative Site 321
state: Florida
city: Orlando
country: United States
facility: Connect Investigative Site 304
state: Florida
city: Weston
country: United States
facility: Connect Investigative Site 340
state: Florida
city: Chicago
country: United States
facility: Connect Investigative Site 333
state: Illinois
city: Chicago
country: United States
facility: Connect Investigative Site 303
state: Illinois
city: New Albany
country: United States
facility: Connect Investigative Site 307
state: Indiana
city: West Lafayette
country: United States
facility: Connect Investigative Site 313
state: Indiana
city: Louisville
country: United States
facility: Connect Investigative Site 311
state: Kentucky
city: Hunt Valley
country: United States
facility: Connect Investigative Site 319
state: Maryland
city: Saint Joseph
country: United States
facility: Connect Investigative Site 335
state: Missouri
city: Saint Louis
country: United States
facility: Connect Investigative Site 315
state: Missouri
city: Las Vegas
country: United States
facility: Connect Investigative Site 336
state: Nevada
city: Albuquerque
country: United States
facility: Connect Investigative Site 326
state: New Mexico
city: Cincinnati
country: United States
facility: Connect Investigative Site 330
state: Ohio
city: Rapid City
country: United States
facility: Connect Investigative Site 328
state: South Dakota
city: Memphis
country: United States
facility: Connect Investigative Site 309
state: Tennessee
city: Houston
country: United States
facility: Connect Investigative Site 334
state: Texas
city: Canberra
country: Australia
facility: Connect Investigative Site 111
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Connect Investigative Site 104
state: New South Wales
city: Kanwal
country: Australia
facility: Connect Investigative Site 108
state: New South Wales
city: Sydney
country: Australia
facility: Connect Investigative Site 105
state: New South Wales
city: Brisbane
country: Australia
facility: Connect Investigative Site 101
state: Queensland
city: Melbourne
country: Australia
facility: Connect Investigative Site 102
state: Victoria
city: Fremantle
country: Australia
facility: Connect Investigative Site 106
state: Western Australia
city: Perth
country: Australia
facility: Connect Investigative Site 103
state: Western Australia
city: Beijing
country: China
facility: Connect Investigative Site 408
state: Beijing
city: Beijing
country: China
facility: Connect Investigative Site 404
state: Beijing
city: Wuxi
country: China
facility: Connect Investigative Site 405
state: Jiangsu
city: Zhenjiang
country: China
facility: Connect Investigative Site 409
state: Jiangsu
city: Jinan
country: China
facility: Connect Investigative Site 402
state: Shandong
city: Shanghai
country: China
facility: Connect Investigative Site 401
state: Shanghai
city: Shanghai
country: China
facility: Connect Investigative Site 406
state: Shanghai
city: Tianjin
country: China
facility: Connect Investigative Site 410
state: Tianjin
city: Hangzhou
country: China
facility: Connect Investigative Site 403
state: Zhejiang
city: Tauranga
country: New Zealand
facility: Connect Investigative Site 204
state: Bay Of Plenty
city: Havelock North
country: New Zealand
facility: Connect Investigative Site 202
state: Hawke's Bay
city: Waikanae
country: New Zealand
facility: Connect Investigative Site 205
state: Kapiti Coast
city: Auckland
country: New Zealand
facility: Connect Investigative Site 203
Study officials:
affiliation: Connect Biopharm LLC
name: Suzhou Connect
role: STUDY_DIRECTOR
References: