Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (SHINE)

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: Placebo; Drug: IFX-1

Detailed Description

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1431
    • InflaRX Investigational Site
  • Sofia, Bulgaria, 1606
    • InflaRX Investigational Site
  • Stara Zagora, Bulgaria, 6003
    • InflaRX Investigational Site
• Canada
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1C 2H5
      • InflaRX Investigational Site
  • Ontario
    • Peterborough, Ontario, Canada, K9J 5K2
      • InflaRX Investigational Site
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • InflaRX Investigational Site
• Denmark
  • Copenhagen, Denmark, 2400
    • InflaRX Investigational Site
  • Roskilde, Denmark, 4000
    • InflaRX Investigational Site
• France
  • Paris, France, 75475
    • InflaRX Investigational Site
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06202
      • InflaRX Investigational Site
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • InflaRX Investigational Site
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • InflaRX Investigational Site
  • Hauts De Seine
    • Antony, Hauts De Seine, France, 92160
      • InflaRX Investigational Site
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • InflaRX Investigational Site
• Germany
  • Hessen
    • Darmstadt, Hessen, Germany, 64297
      • InflaRX Investigational Site
    • Frankfurt, Hessen, Germany, 60590
      • InflaRX Investigational Site
  • Nordrhein Westfalen
    • Bochum, Nordrhein Westfalen, Germany, 44791
      • InflaRX Investigational Site
  • Sachsen Anhalt
    • Dessau, Sachsen Anhalt, Germany, 06847
      • InflaRX Investigational Site
• Greece
  • Athens, Greece, 115 25
    • InflaRX Investigational Site
  • Athens, Greece, 12462
    • InflaRX Investigational Site
  • Thessaloníki, Greece, 54645
    • InflaRX Investigational Site
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • InflaRX Investigational Site
• Poland
  • Gdańsk, Poland, 80-402
    • InflaRX Investigational Site
  • Kraków, Poland, 30-033
    • InflaRX Investigational Site
  • Kłodzko, Poland, 57-300
    • InflaRX Investigational Site
  • Wrocław, Poland, 50-566
    • InflaRX Investigational Site
  • Wrocław, Poland, 51-318
    • InflaRX Investigational Site
  • Łódź, Poland, 90-436
    • InflaRX Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • InflaRX Investigational Site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • InflaRX Investigational Site
    • Miami, Florida, United States, 33136
      • InflaRX Investigational Site
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • InflaRX Investigational Site
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • InflaRX Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • InflaRX Investigational Site
    • Saint Joseph, Missouri, United States, 64506
      • InflaRX Investigational Site
    • Saint Louis, Missouri, United States, 63104
      • InflaRX Investigational Site
    • Saint Louis, Missouri, United States, 63110
      • InflaRX Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • InflaRX Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • InflaRX Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • InflaRX Investigational Site
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • InflaRX Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, ≥ 18 years of age
• Written informed consent obtained from subject
• Diagnosis of HS for at least 1 year
• Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of which must be at least Hurley Stage II or Stage III
• Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics
• Total abscess and inflammatory nodule (AN) count of ≥ 3

Exclusion Criteria:

• Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening
• Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline only) who have not been on a stable dose during the 28 days before Screening
• Subject received systemic non-biologic therapy for HS with potential therapeutic impact for HS during the 28 days before Screening (other than permitted oral antibiotics)

• Prior treatment with any of the following medications during the 28 days before Screening:

  • Any other systemic therapy for HS
  • Any iv anti-infective therapy
  • Phototherapy (ultraviolet B or psoralen and ultraviolet A)
• History of heart disease or malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cohort 1; Placebo	Drug: Placebo; Placebo
Experimental: Cohort 2; Minimum Dose IFX-1 (400 mg Q4W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29; Vilobelimab
Experimental: Cohort 3; Low dose IFX-1 (800 mg Q4W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29; Vilobelimab
Experimental: Cohort 4; Medium Dose IFX-1 (800 mg Q2W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29; Vilobelimab
Experimental: Cohort 5; High Dose IFX-1 (1200 mg Q2W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29; Vilobelimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16	The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12	Endpoint of the percentage of patients with HiSCR at Week 12 was analyzed in the same way as the primary endpoint using the MCP-Mod procedure and the same definition of response.	Week 12
Number of Patients With Flares Relative to Day 1	The number of patients with flares analyzed in terms of ≥ 25% increase in abscess and inflammatory nodule (AN) count among patients with a minimum increase of 2 in AN count compared to Day 1 was analyzed by descriptive statistics by time point.	From Day 1 until Day 309
Absolute Change in Modified Sartorius Score (mSS) From Day 1.	The absolute change from Day 1 will be analyzed by descriptive statistics by time point. The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.	From Day 1 until Day 309
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.	The absolute changes from baseline were analyzed by descriptive statistics by time point. The Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. The scale title for the NRS is points. Ratings for this item range from a minimum of 0 points (no skin pain) to a maximum of 10 points (skin pain as bad as you can imagine). The higher the score the more severe the disease/worse is the outcome.	From Day 1 until Day 309
Percentage of Patients Achieving NRS30	This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for the NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 30% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.	From Day 1 until Day 309
Percentage of Patients Achieving NRS50.	This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The scale title for NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 50% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.	From Day 1 until Day 309
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.	The changes from Day 1 will be analyzed by descriptive statistics by time point. A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.	From Day 1 until Day 309
Safety Parameters (Adverse Events) Will be Assessed.	The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.	From Day 1 until Day 309

Collaborators and Investigators

• Sponsor: InflaRx GmbH
• Collaborators: Quintiles, Inc.
• Investigators: Study Director: Othmar Zenker, CMO, InflaRx GmbH

Publications and helpful links

General Publications

• Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Actual): May 27, 2019
• Study Completion (Actual): January 27, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; monoclonal antibody; skin diseases; hidradenitis suppurativa; complement factor C5a; IFX-1; hidradenitis Suppurativa Clinical Response
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Complement Inactivating Agents; Vilobelimab
• Other Study ID Numbers: IFX-1-P2.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No