BridgeMD
Tests treatment safety and results for Adult Subjects With Non-Segmental Vitiligo
Official title A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Non-Segmental Vitiligo
ClinicalTrials.gov ID: NCT07712523
What this study is testing
What is QY201 Tablets(5mg）?
QY201 Tablets(5mg） is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adult subjects with non-segmental vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of QY201 Tablets in adult subjects with non-segmental vitiligo, and to provide evidence for dose selection in the confirmatory Phase III clinical trial.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- The subject is able to communicate well with investigators, fully understands the purpose, nature, methods and potential adverse reactions of this...
- At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
- Clinically diagnosed with non-segmental vitiligo at screening.
- people must meet the following criteria at screening and baseline: F-VASI ≥ 0.5 and T-VASI ≥ 5 at both screening and baseline; The disease is in...
- The subject (and partner if applicable) agrees to avoid pregnancy and adopt effective contraceptive measures from ICF signature through 3 months...
You likely can't join if
- Received any of the following treatments within 12 weeks prior to baseline (or 5 half-lives, whichever is longer): Small-molecule targeted drugs...
- Received phototherapy (e.g., ultraviolet B [UVB], psoralen plus ultraviolet A [PUVA], excimer laser or other laser modalities, etc.) including indoor...
- Received any of the following systemic therapies within 4 weeks prior to baseline (or 5 half-lives, whichever is longer): Systemic immunosuppressive...
- Received any of the following topical treatments within 2 weeks prior to baseline: Topical corticosteroids (TCS); Topical calcineurin inhibitors...
- Has a history of permanent depigmentation therapy (e.g., monobenzone, phenol) for vitiligo and/or other pigmentary disorders at any time prior to...
- Has a history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical interventions for vitiligo.
See the full eligibility criteria
- The subject is able to communicate well with investigators, fully understands the purpose, nature, methods and potential adverse reactions of this trial, voluntarily participates as a study subject, comprehends and...
- At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
- Clinically diagnosed with non-segmental vitiligo at screening.
- people must meet the following criteria at screening and baseline: F-VASI ≥ 0.5 and T-VASI ≥ 5 at both screening and baseline; The disease is in progressive (active) phase or stable phase at screening and baseline...
- The subject (and partner if applicable) agrees to avoid pregnancy and adopt effective contraceptive measures from ICF signature through 3 months after the last study drug administration. Male people: must commit not to...
- Received any of the following treatments within 12 weeks prior to baseline (or 5 half-lives, whichever is longer): Small-molecule targeted drugs; Macromolecular biological agents.
- Received phototherapy (e.g., ultraviolet B [UVB], psoralen plus ultraviolet A [PUVA], excimer laser or other laser modalities, etc.) including indoor tanning within 12 weeks prior to baseline.
- Received any of the following systemic therapies within 4 weeks prior to baseline (or 5 half-lives, whichever is longer): Systemic immunosuppressive or immunomodulatory drugs; Systemic Chinese herbal medicines or...
- Received any of the following topical treatments within 2 weeks prior to baseline: Topical corticosteroids (TCS); Topical calcineurin inhibitors (TCI); Topical phosphodiesterase 4 (PDE-4) inhibitors; Topical vitamin D3...
- Has a history of permanent depigmentation therapy (e.g., monobenzone, phenol) for vitiligo and/or other pigmentary disorders at any time prior to screening.
- Has a history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical interventions for vitiligo.
- Taken strong inhibitors or strong inducers of cytochrome P450 3A (CYP3A) hepatic metabolic enzymes within 2 weeks prior to baseline.
- Received long-acting anticoagulants (e.g., warfarin, clopidogrel, etc.) within 4 weeks prior to baseline, or requires continuous anticoagulant therapy (excluding aspirin at a dose ≤100 mg per day).
- Planned to receive live or attenuated live vaccines within 4 weeks prior to baseline; or expects to receive live or attenuated live vaccines during the study period (including at least 4 weeks after the last dose of...
- Has participated in any clinical trial involving an investigational drug within 4 weeks prior to baseline (or 5 half-lives, whichever is longer), or any clinical trial with an investigational medical device within 3...
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.