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

NCT06397911 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FB825CLRS02
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The percentage change from baseline in Eczema Area and Severity Index (EASI) score

  Week 16

Secondary Outcomes (12)

• The percentage change from baseline in Eczema Area and Severity Index (EASI) score

  Week 2, 4, 8, 12, 20 and 24

• The mean change from baseline in Eczema Area and Severity Index (EASI) score

  Week 2, 4, 8, 12, 16, 20, and 24

• Proportion of patients with EASI-75 (≥75% improvement from baseline)

  Week 2, 4, 8, 12, 16, 20, and 24

• Proportion of patients with EASI-50 (≥50% improvement from baseline)

  Week 2, 4, 8, 12, 16, 20, and 24

• Proportion of patients with EASI-90

  Week 2, 4, 8, 12, 16, 20, and 24

Study Arms (2)

FB825

EXPERIMENTAL

Drug: FB825

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FB825 DRUG

The study treatment will be administered as 5 SC doses in total 12 weeks

FB825

Placebo DRUG

The study treatment will be administered as 5 SC doses in total 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria to be included in the study:
• The subject is male or female between 18 and 65 years of age at the time of giving informed consent.
• Body weight equal to or greater than 40 Kg at the time of screening.
• The subject has a physician-confirmed diagnosis of moderate-to-severe atopic dermatitis based on 12 months history of symptoms designated by Hanifin and Rajka criteria.
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits.
• Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 (5-point scale) at the screening and baseline visits.
• ≥10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
• Baseline pruritus numerical rating scale (NRS) average score for maximum itch intensity of ≥ 3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.
• History of inadequate response to a stable (4 weeks) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD within 6 months before the screening visit. (The TCS should belong to medium to high potency strength and has been applied for at least 4 weeks or for the maximum duration recommended by product prescribing information.)
• An inadequate response is defined as the inability to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD 0=clear to 2=mild).
• Subjects with systemic treatment for AD in the past 6 months were also considered as inadequate responders to topical treatments.
• Patients must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit.
• Female subjects must have a negative serum pregnancy test at screening. All subjects of childbearing potential and his/her sexual partner must meet 2 following condition or acceptable methods of birth control throughout the study.
• Oral, injectable, or implanted hormonal contraceptives
• Condom with a spermicidal form, gel, film, cream, or suppository

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Female subjects who are pregnant or lactating
• The subject with positive test results for HBeAg or HCV RNA should be excluded as they are indications of active hepatitis B virus and hepatitis C virus replication.
• A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or a history of HIV infection.
• The subject has a history of alcohol or drug abuse within one year prior to screening that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
• The subject has a clinically significant, currently active or severe gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis and allergic asthma), inflammatory, immunological, endocrine, diabetes, obesity \[BMI≥35\] or infectious disease and is ineligible to participate in the study as judged by the investigator.
• The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.
• The subject has any history of a previous anaphylactic reaction.
• The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.
• The subject has received TCS or TCI within 7 days prior to the baseline visit (Day 1).
• The subject has received any immunoglobulin products or blood products within 3 months prior to baseline visit.
• The subject has received a biologic product (including investigational biologic product) within 5 half-lives or 3 months, whichever is longer, before baseline visit.
• The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before baseline visit.
• Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period.
• Initiation of treatment of AD with sedative anti-histamine products during the screening period (patients may continue using stable doses of non-sedative anti-histamine).

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (16)

First OC Dermatology

Fountain Valley, California, 92708, United States

RECRUITING

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

RECRUITING

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

RECRUITING

University of California, Davis Health, Department of Dermatology

Sacramento, California, 95816, United States

RECRUITING

UT Health Science Houston

Bellaire, Texas, 77401, United States

RECRUITING

Center for Clinical Studies

Webster, Texas, 77598, United States

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

New Taipei City, Taiwan

RECRUITING

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chia-Yu Chu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Ho

CONTACT

02-2703-1098; jessica.ho@onenessbio.com.tw

Reo Yang

CONTACT

02-2703-1098; reo.yang@onenessbio.com.tw

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

Model Details: Biological: FB825 Other: Placebo

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (6); TW (10)