A Phase 1 interventional study of FB102 and Placebo in Vitiligo, sponsored by Forte Biosciences, Inc.. Active, not recruiting at 6 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Forte Biosciences, Inc. (part of argenx) · Phase 1, Interventional, and Treatment
A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 64 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Forte Biosciences, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
First submitted before Forte Biosciences, Inc. became part of argenx.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria
Exclusion Criteria:
Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive FB102.
Drug: FB102
Matching placebo
Drug: Placebo
Route of administration- Intravenous (IV)
Route of administration- Intravenous (IV)
Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102
Time frame: Upto 16 Weeks post first dose administration
Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI)
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FB102