Clinical Trial: Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa

Brief 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)).

Detailed Summary:
Sponsor: InflaRx GmbH

Current Primary Outcome:

  • Number of patients with at least possibly related treatment-emergent adverse events (TEAEs) [ Time Frame: up to Day 134 ]
  • Number of patients with detection of anti-drug antibodies (pre-/post-dosing) [ Time Frame: up to Day 134 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Plasma concentration of IFX-1 [ Time Frame: From Day 1 until Day 134 ]
  • Plasma concentration of C5a [ Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 ]
  • Percentage change from baseline in total abscess and nodule (AN) count per time point [ Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 ]
  • Hidradenitis Suppurativa Clinical Response (HiSCR) per time point [ Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 ]
  • Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline [ Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 ]
  • HS-PGA score per time point [ Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 ]
  • Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm [ Time Frame: At each visit from Day 1 until Day 134 ]
  • VAS pain score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  • Change from baseline in VAS pain score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  • VAS disease score per time [ Time Frame: At each visit from Day 1 until Day 134 ]
  • Change from baseline in VAS disease score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  • Dermatology Life Quality Index (DLQI) per time point [ Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 ]
  • Change from baseline in DLQI per time point [ Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 ]


Original Secondary Outcome: Same as current

Information By: InflaRx GmbH

Dates:
Date Received: November 29, 2016
Date Started: December 2016
Date Completion: July 2017
Last Updated: March 20, 2017
Last Verified: March 2017