Trials / Completed
CompletedNCT03001622
Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- InflaRx GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IFX-1 | chimeric, monoclonal antibody |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2016-12-23
- Last updated
- 2017-09-19
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT03001622. Inclusion in this directory is not an endorsement.