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Study of FB825 for Moderate-to-Severe Atopic Dermatitis

This study is looking at a new treatment called FB825 for adults with moderate-to-severe atopic dermatitis (a type of eczema). Researchers want to see how well FB825 works and if it is safe. You would receive either FB825 or a placebo (an inactive substance) through 5 injections under the skin over 12 weeks. The main way success will be measured is by looking at changes in your eczema severity using a score called EASI (Eczema Area and Severity Index) after 16 weeks. To join, you must be between 18 and 65 years old, weigh at least 40 kg, and have a doctor-confirmed diagnosis of moderate-to-severe atopic dermatitis. The current status of this study is unclear.

Study design
This is a randomized, double-blind study, meaning you will be randomly assigned to receive either FB825 or a placebo, and neither you nor your doctor will know which you are receiving. Approximately 90 people will participate, with about 45 in each group.
What's involved
Your participation in the study will last up to 28 weeks, including up to 4 weeks for screening, a 12-week treatment period with 5 injections, and a 12-week follow-up.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 weeks after your last study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06397911

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Oneness Biotech Co., Ltd.
~114 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:FB825Placebo

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Measured over Week 16

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

16 sites across 3 states
Taiwan10
California4
Texas2

Study leadership

  • Chia-Yu Chu · PRINCIPAL_INVESTIGATOR · National Taiwan University Hospital

Who to contact

Jessica Ho
[email protected]
02-2703-1098
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 9. 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.
Oral, injectable, or implanted hormonal contraceptives
Condom with a spermicidal form, gel, film, cream, or suppository
Occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository
Intrauterine device
Intrauterine system (for example, progestin-releasing coil) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or vasectomy)
Postmenopausal (defined as amenorrhea 12 consecutive months and documented serum follicle stimulating hormone level per laboratory standard) Note: The subject must utilize the method of effective contraception during study period as well as 16 weeks or 5 half-lives following the last dosing of FB825. 11. The subject is able to provide written informed consent. 12. The subject agrees to and is capable of adhering to scheduled visits, the treatment plan, laboratory tests, other study procedures, and all protocol requirements.

Exclusion

Subjects to whom any of the following applies will be excluded from the study:
Systemic corticosteroids within 4 weeks.
Leukotriene modifiers within 4 weeks.
Cyclosporine within 4 weeks, or other immunosuppressants (e.g. gold salts, methotrexate, azathioprine) within 4 weeks.
IFN-γ within 12 weeks, or other immunomodulating drugs within 4 weeks.
Allergen immunotherapy within 1 year.
JAK inhibitor within 4 weeks. 19. The subject has received phototherapy within 4 weeks before the study drug treatment. 20. The subject has received live vaccine within 12 weeks before the study drug treatment. 21. The subject has presence of skin comorbidities that may interfere with study assessments. 22. The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment. 23. The subject has active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.

What this trial measures

  • The percentage change from baseline in Eczema Area and Severity Index (EASI) scoreWeek 16