Clinical trial NCT03487276: Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (HS)
Keywords: hidradenitis suppurativa
monoclonal antibody
complement factor C5a
IFX-1
hidradenitis Suppurativa Clinical Response
Inflammation
skin diseases
Lead sponsor: InflaRx GmbH
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2018-04-04
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
timeFrame: Week 12
measure: Number of Patients With Flares Relative to Day 1
timeFrame: From Day 1 until Day 309
measure: Absolute Change in Modified Sartorius Score (mSS) From Day 1.
timeFrame: From Day 1 until Day 309
measure: Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
timeFrame: From Day 1 until Day 309
measure: Percentage of Patients Achieving NRS30
timeFrame: From Day 1 until Day 309
measure: Percentage of Patients Achieving NRS50.
timeFrame: From Day 1 until Day 309
measure: Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
timeFrame: From Day 1 until Day 309
measure: Safety Parameters (Adverse Events) Will be Assessed.
timeFrame: From Day 1 until Day 309
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: InflaRX Investigational Site
state: Alabama
city: Fort Myers
country: United States
facility: InflaRX Investigational Site
state: Florida
city: Miami
country: United States
facility: InflaRX Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: InflaRX Investigational Site
state: Georgia
city: Dearborn
country: United States
facility: InflaRX Investigational Site
state: Michigan
city: Columbia
country: United States
facility: InflaRX Investigational Site
state: Missouri
city: Saint Joseph
country: United States
facility: InflaRx Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: InflaRX Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: InflaRX Investigational Site
state: Missouri
city: Chapel Hill
country: United States
facility: InflaRX Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: InflaRX Investigational Site
state: Ohio
city: Hershey
country: United States
facility: InflaRX Investigational Site
state: Pennsylvania
city: Goodlettsville
country: United States
facility: InflaRx Investigational Site
state: Tennessee
city: Sofia
country: Bulgaria
facility: InflaRX Investigational Site
city: Sofia
country: Bulgaria
facility: InflaRX Investigational Site
city: Stara Zagora
country: Bulgaria
facility: InflaRX Investigational Site
city: Saint John's
country: Canada
facility: InflaRX Investigational Site
state: Newfoundland and Labrador
city: Peterborough
country: Canada
facility: InflaRX Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: InflaRX Investigational Site
state: Ontario
city: Copenhagen
country: Denmark
facility: InflaRX Investigational Site
city: Roskilde
country: Denmark
facility: InflaRX Investigational Site
city: Nice
country: France
facility: InflaRX Investigational Site
state: Alpes Maritimes
city: Bordeaux
country: France
facility: InflaRX Investigational Site
state: Gironde
city: Toulouse
country: France
facility: InflaRX Investigational Site
state: Haute Garonne
city: Antony
country: France
facility: InflaRX Investigational Site
state: Hauts De Seine
city: Nantes
country: France
facility: InflaRX Investigational Site
state: Loire Atlantique
city: Paris
country: France
facility: InflaRX Investigational Site
city: Darmstadt
country: Germany
facility: InflaRX Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: InflaRX Investigational Site
state: Hessen
city: Bochum
country: Germany
facility: InflaRX Investigational Site
state: Nordrhein Westfalen
city: Dessau
country: Germany
facility: InflaRX Investigational Site
state: Sachsen Anhalt
city: Athens
country: Greece
facility: InflaRX Investigational Site
city: Athens
country: Greece
facility: InflaRX Investigational Site
city: Thessaloníki
country: Greece
facility: InflaRX Investigational Site
city: Rotterdam
country: Netherlands
facility: InflaRX Investigational Site
city: Gdańsk
country: Poland
facility: InflaRX Investigational Site
city: Kraków
country: Poland
facility: InflaRX Investigational Site
city: Kłodzko
country: Poland
facility: InflaRX Investigational Site
city: Wrocław
country: Poland
facility: InflaRX Investigational Site
city: Wrocław
country: Poland
facility: InflaRX Investigational Site
city: Łódź
country: Poland
facility: InflaRX Investigational Site
Study officials:
affiliation: InflaRx GmbH
name: Othmar Zenker, CMO
role: STUDY_DIRECTOR
References:
citation: 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.