NCT06905873 A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
| NCT ID | NCT06905873 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Forte Biosciences, Inc. |
| Condition | Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2025-03-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged ≥ 18 to 75 years at time of Screening. 2. Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator. 3. If receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria Exclusion Criteria: 1. Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus). 2. Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment. 3. Greater than approximately 33% leukotrichia (depigmentation of the hair) in areas of vitiligo on the face as assessed by a healthcare professional at the time of screening. Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
Frequently Asked Questions
Who can join the NCT06905873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Vitiligo. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06905873 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06905873 currently recruiting?
Yes, NCT06905873 is actively recruiting participants. Visit ClinicalTrials.gov or contact Forte Biosciences, Inc. to inquire about joining.
Where is the NCT06905873 trial being conducted?
This trial is being conducted at Darlinghurst, Australia, Kotara, Australia, Coorparoo, Australia, Auckland, New Zealand and 2 additional locations.
Who is sponsoring the NCT06905873 clinical trial?
NCT06905873 is sponsored by Forte Biosciences, Inc.. The trial plans to enroll 64 participants.