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Recruiting NCT06905873

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo

Phase I Interventional Vitiligo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FB102, Placebo.
Who it may be relevant to
Registry conditions: Vitiligo. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo

Overview

A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.

Detailed description

Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.

Interventions

  • Drug FB102
    Route of administration- Intravenous (IV)
  • Drug Placebo
    Route of administration- Intravenous (IV)

Primary outcome measures

  • 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) [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) [Time frame: Upto 16 Weeks post first dose administration]
Secondary outcome measures (2)
  • Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline. [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) [Time frame: Upto 16 Weeks post first dose administration]

Eligibility criteria

Inclusion criteria

  • Males and females aged ≥ 18 to 75 years at time of Screening.
  • Must have confirmed non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit, as assessed by the study investigator.
  • 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

  • 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).
  • 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • Skin & Cancer Foundation Australia - The Skin Hospital — Darlinghurst
  • Novatrials — Kotara
  • Cornerstone Dermatology — Coorparoo
New Zealand · 3 centers
  • Optimal Clinical Trials North — Auckland
  • Optimal Clinical Trials Central — Auckland
  • Momentum Pukehoke — Auckland

Identifiers

NCT: NCT06905873 · FB102-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗