Actively Recruiting
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
Led by Oneness Biotech Co., Ltd. · Updated on 2025-09-22
90
Participants Needed
16
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 65 years old
- Body weight 40 kg or more at screening
- Physician-confirmed moderate-to-severe atopic dermatitis with symptoms for at least 12 months
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Investigator Global Assessment score of 3 or greater at screening and baseline
- At least 10% body surface area affected by atopic dermatitis at screening and baseline
- Average itch intensity score of 3 or higher over 7 days before randomization
- Inadequate response to stable topical corticosteroids or calcineurin inhibitors within 6 months before screening
- Use of stable doses of additive-free bland emollient twice daily for at least 1 week before baseline
- Female subjects must have a negative pregnancy test and use effective contraception during the study and for 16 weeks after last dose
- Able to provide written informed consent
- Willing and able to follow study visits, treatment plan, tests, and procedures
You will not qualify if you...
- Pregnant or breastfeeding females
- Positive tests indicating active hepatitis B or C infection
- Positive HIV test or history of HIV infection
- History of alcohol or drug abuse within 1 year before screening
- Significant active or severe diseases (gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory except mild allergies, inflammatory, immunological, endocrine, diabetes, obesity with BMI ≥35, infectious) preventing participation
- History of drug allergies or hypersensitivity including sulfonamides and penicillin
- History of anaphylactic reaction
- Conditions that could compromise study participation or safety
- Use of topical corticosteroids or calcineurin inhibitors within 7 days before baseline
- Use of immunoglobulin or blood products within 3 months before baseline
- Use of biologic products within 5 half-lives or 3 months before baseline
- Use of investigational drugs within 8 weeks or 5 half-lives before baseline
- Starting new prescription moisturizers with additives during screening
- Starting sedative antihistamines during screening (non-sedative antihistamines allowed if stable)
- Involvement in the study as professional or ancillary personnel
- Regular tanning booth use (≥2 times per week) within 4 weeks before baseline
- Use of cell-based immunotherapy within 3 months before baseline
- Use of certain medications (systemic corticosteroids, leukotriene modifiers, cyclosporine, immunosuppressants, interferon gamma, immunomodulators, allergen immunotherapy, JAK inhibitors) within specified time frames before treatment
- Phototherapy within 4 weeks before treatment
- Live vaccine within 12 weeks before treatment
- Skin conditions that interfere with assessments
- Known or suspected immunosuppression or history of opportunistic infections
- Active infections requiring systemic treatment within 2 weeks or skin infections within 1 week before baseline
- History of malignancy within 5 years except certain treated skin or cervical cancers
- Planned use of prohibited medications or procedures during study
- Planned major surgery during study
- High risk or evidence of parasitic infection based on risk factors and stool evaluation if indicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
First OC Dermatology
Fountain Valley, California, United States, 92708
Actively Recruiting
2
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Actively Recruiting
3
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
Actively Recruiting
4
University of California, Davis Health, Department of Dermatology
Sacramento, California, United States, 95816
Actively Recruiting
5
UT Health Science Houston
Bellaire, Texas, United States, 77401
Actively Recruiting
6
Center for Clinical Studies
Webster, Texas, United States, 77598
Actively Recruiting
7
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
8
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Actively Recruiting
9
Linkou Chang Gung Memorial Hospital
New Taipei City, Taiwan
Actively Recruiting
10
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan
Actively Recruiting
11
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
12
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
13
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
14
Taipei Mackay Memorial Hospital
Taipei, Taiwan
Actively Recruiting
15
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
16
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
J
Jessica Ho
CONTACT
R
Reo Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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