Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Oneness Biotech Co., Ltd.
Study ID
NCT06397911
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • FB825 — DRUG
    The study treatment will be administered as 5 SC doses in total 12 weeks
  • Placebo — DRUG
    The study treatment will be administered as 5 SC doses in total 12 weeks

Study Details

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.

Key Dates

Start date
Aug 8, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FB825
  • Placebo Comparator: Placebo

Primary Outcome Measure

The percentage change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: Week 16 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
First OC DermatologyFountain ValleyCalifornia92708
Vivian Laquer, Ph D
Center for Dermatology Clinical Research, Inc.FremontCalifornia94538
Sunil Dhawan, MD
Sunil Dhawan, MD (PRINCIPAL_INVESTIGATOR)
California Allergy and Asthma Medical GroupLos AngelesCalifornia90025
Ricardo Tan
University of California, Davis Health, Department of DermatologySacramentoCalifornia95816
Victor Huang, Ph D
UT Health Science HoustonBellaireTexas77401
Adelaide Hebert, Ph D
Center for Clinical StudiesWebsterTexas77598
Patricia Lee

Find similar trials in Fountain Valley, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
First OC Dermatology· Fountain Valley, CACenter for Dermatology Clinical Research, Inc.· Fremont, CACalifornia Allergy and Asthma Medical Group· Los Angeles, CAUniversity of California, Davis Health, Department of Dermatology· Sacramento, CAUT Health Science Houston· Bellaire, TXCenter for Clinical Studies· Webster, TX

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