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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Otsuka Call Center
- Telefonnummer: 844-687-8522
- E-Mail: otsuka-professionalservices@otsuka-us.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: HS Cohort: VIS954
Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-Komparator: HS Cohort: Placebo
Participants with HS will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimental: PG Cohort: VIS954
Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-Komparator: PG Cohort: Placebo
Participants with PG will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
Experimental: BP Cohort: VIS954
Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
Placebo-Komparator: BP Cohort: Placebo
Participants with BP received placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection
Zeitfenster: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events
Zeitfenster: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events
Zeitfenster: Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events
Zeitfenster: Up to Week 36
|
Up to Week 36
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 381-201-00028
- 2026-525969-41-00 (Ctis)
- 1014049 (Andere Kennung: Integrated Research Application System (IRAS))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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