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Not yet recruitingNCT07933445Updated Nov 12, 2026

VIS954 for Treating Inflammatory Skin Problems

A Phase 2 interventional study of VIS954 and Placebo in Inflammatory Skin Diseases, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Inflammatory Skin Diseases

Keywords

  • ISD
  • HS
  • PG
  • BP
03

In context

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 297 studies on the registry; 19 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.

Browse Otsuka Pharmaceutical Development & Commercialization, Inc. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    HS Cohort: VIS954

    Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period.

    Drug: VIS954

  • Placebo comparator
    HS Cohort: Placebo

    Participants with HS will receive placebo in the placebo-controlled period.

    Drug: Placebo

  • Experimental
    PG Cohort: VIS954

    Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period.

    Drug: VIS954

  • Placebo comparator
    PG Cohort: Placebo

    Participants with PG will receive placebo in the placebo-controlled period.

    Drug: Placebo

  • Experimental
    BP Cohort: VIS954

    Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period.

    Drug: VIS954

  • Placebo comparator
    BP Cohort: Placebo

    Participants with BP received placebo in the placebo-controlled period.

    Drug: Placebo

Interventions

  • DrugVIS954

    VIS954 solution for injection

  • DrugPlacebo

    VIS954-matching placebo solution for injection

06

What researchers measure

Primary outcomes

  1. HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection

    Time frame: Up to Week 36

  2. HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events

    Time frame: Up to Week 36

  3. HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events

    Time frame: Up to Week 36

  4. HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events

    Time frame: Up to Week 36

Secondary outcomes

  1. HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils

    Time frame: Predose and at multiple timepoints postdose up to Day 225

  2. HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954

    Time frame: Predose and at multiple timepoints postdose up to Day 253

  3. HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954

    Time frame: Predose and at multiple timepoints postdose up to Day 253

  4. HS, PG, and BP Cohorts: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau)

    Time frame: Predose and at multiple timepoints postdose up to Day 253

  5. HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)

    Time frame: Predose and at multiple timepoints postdose up to Day 253

  6. HS, PG, and BP Cohorts: Apparent Clearance (CL/F)

    Time frame: Predose and at multiple timepoints postdose up to Day 253

  7. HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)

    Time frame: Predose and at multiple timepoints postdose up to Day 253

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

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

Data sharing details ↗ · clinical-trials.otsuka.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Mar 2029, 27 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Mar 13, 2029
CompletionEst.
Mar 13, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933445
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Mar 13, 2029 (estimated)
Completion
Mar 13, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Otsuka Call Center
Contact
otsuka-professionalservices@otsuka-us.com
844-687-8522

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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