VIS954 for Treating Inflammatory Skin Problems
A Phase 2a, Multicenter, Basket Study of VIS954 in Participants With Inflammatory Skin Diseases
This is a phase 2, multicenter, basket study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VIS954 in adults with inflammatory skin diseases (ISDs).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Otsuka Call Center
- Telefonnummer: 844-687-8522
- E-post: otsuka-professionalservices@otsuka-us.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Key Inclusion Criteria
- Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
- HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
- PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
- BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
Key Exclusion Criteria
- Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
- HS-Lack of adequate response, as determined by the investigator.
- PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
- BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: HS Cohort: VIS954
Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-jämförare: HS Cohort: Placebo
Participants with HS will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimentell: PG Cohort: VIS954
Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-jämförare: PG Cohort: Placebo
Participants with PG will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimentell: BP Cohort: VIS954
Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-jämförare: BP Cohort: Placebo
Participants with BP received placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection
Tidsram: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events
Tidsram: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events
Tidsram: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events
Tidsram: Up to Week 36
|
Up to Week 36
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils
Tidsram: Predose and at multiple timepoints postdose up to Day 225
|
Predose and at multiple timepoints postdose up to Day 225
|
|
HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau)
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Clearance (CL/F)
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)
Tidsram: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 381-201-00028
- 2026-525969-41-00 (Ctis)
- 1014049 (Annan identifierare: Integrated Research Application System (IRAS))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Tidsram för IPD-delning
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Kriterier för IPD Sharing Access
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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