WithdrawnPhase 3

CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis

Stopped: Sponsor Decision

0Started 2022-12

Plain-language summary

This is a Phase 3, randomized, double-blinded, placebo-controlled trial in patients, ≥12 years of age who weigh ≥40 kg, and are diagnosed with moderate-to-severe AD.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Involvement of ≥ 10% BSA at Screening and Baseline (Day 1).
✓. An EASI score of ≥ 16 at Screening and Baseline (Day 1).
✓. An IGA score of ≥ 3 at Screening and Baseline (Day 1).
✓. Baseline weekly average of daily PP-NRS ≥ 4 at Baseline (Day1).

Exclusion criteria

✕. Other active skin diseases (e.g., psoriasis, lupus erythematosus etc.) or skin infections (bacterial, fungal, or viral) that require systemic treatment within 4 weeks of Screening Visit or would interfere with the assessment of AD lesions.
✕. History of recurrent herpes herpeticum in the prior 12 months or more than 2 episodes of herpes herpeticum in past 2 years.
✕. Non-skin related active infection requiring systemic treatment with parenteral anti-infectives within 30 days or oral anti-infectives within 14 days before the Baseline Visit (Visit 2).
✕. Active human immunodeficiency virus (HIV) defined as a confirmed positive anti-HIV antibody test.
✕. Tuberculosis requiring treatment within the past 12 months before Screening. Note: Evaluation of tuberculosis will be according to local guidelines as per standard of care.
✕. Active Hepatitis B virus (HBV) or hepatitis C virus (HCV).
✕. HCV: HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab).
✕. Known primary immunodeficiency or immunocompromised

What they're measuring

Investigator Global Assessment(IGA)(0-1)

Timeframe: Baseline to Week16

EASI-75

Timeframe: Baseline at Week 16

Trial details

NCT IDNCT05614817

SponsorConnect Biopharm LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Atopic Dermatitis trials