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).

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Skin Diseases
• Intervention / Treatment: Drug: VIS954; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Otsuka Call Center; Phone Number: 844-687-8522; Email: otsuka-professionalservices@otsuka-us.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria

1. Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
2. 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.
3. 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.
4. 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

1. 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.
2. HS-Lack of adequate response, as determined by the investigator.
3. 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.
4. BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS Cohort: VIS954; Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period.	Drug: VIS954; VIS954 solution for injection
Placebo Comparator: HS Cohort: Placebo; Participants with HS will receive placebo in the placebo-controlled period.	Drug: Placebo; 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.	Drug: VIS954; VIS954 solution for injection
Placebo Comparator: PG Cohort: Placebo; Participants with PG will receive placebo in the placebo-controlled period.	Drug: Placebo; 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.	Drug: VIS954; VIS954 solution for injection
Placebo Comparator: BP Cohort: Placebo; Participants with BP received placebo in the placebo-controlled period.	Drug: Placebo; VIS954-matching placebo solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection	Up to Week 36
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events	Up to Week 36
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events	Up to Week 36
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events	Up to Week 36

Secondary Outcome Measures

Outcome Measure	Time Frame
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils	Predose and at multiple timepoints postdose up to Day 225
HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954	Predose and at multiple timepoints postdose up to Day 253
HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954	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)	Predose and at multiple timepoints postdose up to Day 253
HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)	Predose and at multiple timepoints postdose up to Day 253
HS, PG, and BP Cohorts: Apparent Clearance (CL/F)	Predose and at multiple timepoints postdose up to Day 253
HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)	Predose and at multiple timepoints postdose up to Day 253

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

Helpful Links

• <p>Otsuka Clinical Trial Website</p>
• <p>Otsuka Clinical Trial Transparency Website</p>

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): March 13, 2029
• Study Completion (Estimated): March 13, 2029

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: BP; PG; HS; ISD
• Other Study ID Numbers: 381-201-00028; 2026-525969-41-00 (Ctis); 1014049 (Other Identifier: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Time Frame

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 Access Criteria

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No