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Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

NCT06555328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-02-03

No results posted yet for this study

Summary

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Conditions

Interventions

DRUG

CSU lower dose treatment

CSU lower dose treatment

DRUG

CSU high dose treatment

CSU high dose treatment

DRUG

CSU non responders IgE - high dose treatment

CSU non responders IgE - high dose treatment

DRUG

HS low dose treatment

HS low dose treatment

DRUG

HS medium dose treatment

HS medium dose treatment

DRUG

HS high dose treatment

HS high dose treatment

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2026-01-22
Completion
2026-01-22
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Georgia
  • Germany
  • Greece
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06555328 on ClinicalTrials.gov