Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT03001622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2017-09-19
Summary
The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).
Conditions
Interventions
- BIOLOGICAL
-
IFX-1
chimeric, monoclonal antibody
Sponsors & Collaborators
-
InflaRx GmbH
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2017-07-31
- Completion
- 2017-07-31
Countries
- Greece
Study Locations
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