Atopic DermatitisPhase 2NCT06397911
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing FB825 in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- FB825
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 8 Aug 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 22Show fewer
- ≥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.
- Note: See exclusion criterion #13 for limitations regarding emollients.
- 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
- 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.
- The subject is able to provide written informed consent.
- The subject agrees to and is capable of adhering to scheduled visits, the treatment plan, laboratory tests, other study procedures, and all protocol requirements.
Who cannot join
- 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.
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- 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).
- The subject is a member of the professional or ancillary personnel involved in the study.
- The subject regular use (≥2 visits per week) of a tanning booth/parlor within 4 weeks prior to the baseline visit.
- The subject has received cell-based immunotherapy treatment within 3 months prior to baseline visit.
- The subject has used any of the following classes of medication (prescription or over-the-counter) within specific time frames before the study drug treatment:
- 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.
- The subject has received phototherapy within 4 weeks before the study drug treatment.
- The subject has received live vaccine within 12 weeks before the study drug treatment.
- The subject has presence of skin comorbidities that may interfere with study assessments.
- The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.
- 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.
- Note: Patients with resolved infection may be rescreened.
- The subject has history of malignancy within 5 years before the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- The subject has planned or anticipated the use of any prohibited medications and procedures during the entire study period.
- The subject has planned or anticipated major surgical procedure during the entire study period.
- High risk of parasite infection. Evidence of parasitic infection designated as having the following two items:
- Risk factors for parasitic disease include living in an endemic area, experiencing chronic gastrointestinal symptoms, traveling to regions where geohelminthic infections are endemic within the last 6 months, and/or having chronic immunosuppression).
- AND
- Evidence of parasitic colonization or infection found during stool evaluation for ova and parasites.
- Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
Taiwan10 sites, 10 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Chih-Hong Lee, MD, PhD
Chih-Hong Lee, MD, PhD
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Chien-Hui Hong, MD, PhD
Chien-Hui Hong, MD, PhD
- Recruiting
Linkou Chang Gung Memorial Hospital
New Taipei City
Yu-Huei Huang, MD, PhD
Yu-Huei Huang, MD, PhD
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City
Woan-Ruoh Lee
- Recruiting
China Medical University Hospital
Taichung
Po-Yuan Wu, MD, PhD
- Recruiting
National Cheng Kung University Hospital
Tainan
Tak-Wah Wong, MD, PhD
Tak-Wah Wong, MD, PhD
- Recruiting
National Taiwan University Hospital
Taipei
Chia-Yu Chu, MD, PhD
Chia-Yu Chu, MD, PhD
- Recruiting
Taipei Mackay Memorial Hospital
Taipei
Nan-Lin Wu, MD, PhD
Nan-Lin Wu, MD, PhD
- Recruiting
Taipei Veterans General Hospital
Taipei
Chih-Chiang Chen, MD, PhD
Chih-Chiang Chen, MD, PhD
- Recruiting
Tri-Service General Hospital
Taipei
Chih-Tsung Hung, MD, PhD
Chih-Tsung Hung, MD, PhD
United States6 sites, 6 recruiting
- Recruiting
UT Health Science Houston
Bellaire, Texas, 77401
Adelaide Hebert, Ph D
- Recruiting
First OC Dermatology
Fountain Valley, California, 92708
Vivian Laquer, Ph D
- Recruiting
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Sunil Dhawan, MD
Sunil Dhawan, MD
- Recruiting
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Ricardo Tan
- Recruiting
University of California, Davis Health, Department of Dermatology
Sacramento, California, 95816
Victor Huang, Ph D
- Recruiting
Center for Clinical Studies
Webster, Texas, 77598
Patricia Lee
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
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.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis, with approximately 45 subjects per group.
The study duration of subject participation in the study is up to 28 weeks, including up to 4 weeks for screening, a 12-week study intervention and a 12-week follow-up period after study intervention. The study treatment will be administered as 5 SC doses.
- Conditions
- Atopic Dermatitis
- Being tested
- FB825, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB825Drug
The study treatment will be administered as 5 SC doses in total 12 weeks
PlaceboDrug
The study treatment will be administered as 5 SC doses in total 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| FB825 | Experimental | Not described Receives: Drug: FB825 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Measured: Week 16
Secondary outcomes (12)
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Measured: Week 2, 4, 8, 12, 20 and 24
The mean change from baseline in Eczema Area and Severity Index (EASI) score
Measured: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-75 (≥75% improvement from baseline)
Measured: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-50 (≥50% improvement from baseline)
Measured: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-90
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in Investigator Global Assessment (IGA) score
Measured: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with both Investigator Global Assessment (IGA) 0 to 1 and a reduction from baseline of ≥2 points
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) score
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in pruritus numerical rating scale (NRS) score
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The mean change from baseline in Dermatology Life Quality Index (DLQI) score
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in total IgE
Measured: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in allergen-specific IgE
Measured: Week 4, 16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start8 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Biological: FB825 Other: Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Yu Chu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397911
- Sponsor's protocol ID
- FB825CLRS02
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06397911
- Acronym / sponsor ID
- FB825CLRS02
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis, with approximately 45 subjects per group.
The study duration of subject participation in the study is up to 28 weeks, including up to 4 weeks for screening, a 12-week study intervention and a 12-week follow-up period after study intervention. The study treatment will be administered as 5 SC doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Biological: FB825 Other: Placebo
| Arm | Type | Receives |
|---|---|---|
| FB825 | Experimental | Drug: FB825 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (39 listed)
- Subjects to whom any of the following applies will be excluded from the study:
- Note: Patients with resolved infection may be rescreened.
- AND
- Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB825The study treatment will be administered as 5 SC doses in total 12 weeks | Drug | FB825 |
| PlaceboThe study treatment will be administered as 5 SC doses in total 12 weeks | Drug | Placebo |
Primary outcome
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Week 16
12 secondary outcomes
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Week 2, 4, 8, 12, 20 and 24
The mean change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-75 (≥75% improvement from baseline)
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-50 (≥50% improvement from baseline)
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with EASI-90
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in Investigator Global Assessment (IGA) score
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
Proportion of patients with both Investigator Global Assessment (IGA) 0 to 1 and a reduction from baseline of ≥2 points
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) score
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in pruritus numerical rating scale (NRS) score
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The mean change from baseline in Dermatology Life Quality Index (DLQI) score
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in total IgE
Time frame: Week 2, 4, 8, 12, 16, 20, and 24
The percentage change from baseline in allergen-specific IgE
Time frame: Week 4, 16, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chia-Yu Chu principal investigator
National Taiwan University Hospital
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FB825 in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Ho (02-2703-1098, jessica.ho@onenessbio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change from baseline in Eczema Area and Severity Index (EASI) score (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.