Status:
COMPLETED
A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Connect Biopharm LLC
Conditions:
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
- Have any of the following:
- 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)
- A history of parasitic infection (e.g. helminth), within 6 months of Baseline
- 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.
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC)
- 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
- 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
- An allergy to L-histidine, trehalose or Tween (polysorbate) 80
- Women must not be pregnant, planning to become pregnant or breast-feed during the study
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04444752
Start Date
July 17 2020
End Date
September 22 2021
Last Update
August 1 2023
Active Locations (59)
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1
Connect Investigative Site 310
Glendale, Arizona, United States, 85308
2
Connect Investigative Site 338
Phoenix, Arizona, United States, 85001
3
Connect Investigative Site 316
Tempe, Arizona, United States, 85284
4
Connect Investigative Site 305
Little Rock, Arkansas, United States, 72204