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

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IFX-1
Placebo
Sponsored by
InflaRx GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring hidradenitis suppurativa, monoclonal antibody, complement factor C5a, IFX-1, hidradenitis Suppurativa Clinical Response, Inflammation, skin diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRx Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRx Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site
  • InflaRX Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Placebo

Minimum Dose IFX-1 (400 mg Q4W)

Low dose IFX-1 (800 mg Q4W)

Medium Dose IFX-1 (800 mg Q2W)

High Dose IFX-1 (1200 mg Q2W)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 27, 2018
Last Updated
March 15, 2021
Sponsor
InflaRx GmbH
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03487276
Brief Title
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Acronym
SHINE
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InflaRx GmbH
Collaborators
Quintiles, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (HS)
Keywords
hidradenitis suppurativa, monoclonal antibody, complement factor C5a, IFX-1, hidradenitis Suppurativa Clinical Response, Inflammation, skin diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Minimum Dose IFX-1 (400 mg Q4W)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Low dose IFX-1 (800 mg Q4W)
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Medium Dose IFX-1 (800 mg Q2W)
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
High Dose IFX-1 (1200 mg Q2W)
Intervention Type
Drug
Intervention Name(s)
IFX-1
Other Intervention Name(s)
CaCP29, Vilobelimab
Intervention Description
Single IV infusions of IFX-1 diluted in sodium chloride.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
Description
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.
Time Frame
Week 12
Title
Number of Patients With Flares Relative to Day 1
Description
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.
Time Frame
From Day 1 until Day 309
Title
Absolute Change in Modified Sartorius Score (mSS) From Day 1.
Description
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.
Time Frame
From Day 1 until Day 309
Title
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
Description
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.
Time Frame
From Day 1 until Day 309
Title
Percentage of Patients Achieving NRS30
Description
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.
Time Frame
From Day 1 until Day 309
Title
Percentage of Patients Achieving NRS50.
Description
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.
Time Frame
From Day 1 until Day 309
Title
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
Description
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.
Time Frame
From Day 1 until Day 309
Title
Safety Parameters (Adverse Events) Will be Assessed.
Description
The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.
Time Frame
From Day 1 until Day 309

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Othmar Zenker, CMO
Organizational Affiliation
InflaRx GmbH
Official's Role
Study Director
Facility Information:
Facility Name
InflaRX Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
InflaRX Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
InflaRX Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
InflaRX Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
InflaRX Investigational Site
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
InflaRX Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
InflaRx Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
InflaRX Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
InflaRX Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
InflaRX Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
InflaRX Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
InflaRX Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
InflaRx Investigational Site
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
InflaRX Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
InflaRX Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
InflaRX Investigational Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
InflaRX Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
Facility Name
InflaRX Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
InflaRX Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
InflaRX Investigational Site
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
InflaRX Investigational Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
InflaRX Investigational Site
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
InflaRX Investigational Site
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Name
InflaRX Investigational Site
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
InflaRX Investigational Site
City
Antony
State/Province
Hauts De Seine
ZIP/Postal Code
92160
Country
France
Facility Name
InflaRX Investigational Site
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
InflaRX Investigational Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
InflaRX Investigational Site
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
Facility Name
InflaRX Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
InflaRX Investigational Site
City
Bochum
State/Province
Nordrhein Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
InflaRX Investigational Site
City
Dessau
State/Province
Sachsen Anhalt
ZIP/Postal Code
06847
Country
Germany
Facility Name
InflaRX Investigational Site
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
InflaRX Investigational Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
InflaRX Investigational Site
City
Thessaloníki
ZIP/Postal Code
54645
Country
Greece
Facility Name
InflaRX Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
InflaRX Investigational Site
City
Gdańsk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
InflaRX Investigational Site
City
Kraków
ZIP/Postal Code
30-033
Country
Poland
Facility Name
InflaRX Investigational Site
City
Kłodzko
ZIP/Postal Code
57-300
Country
Poland
Facility Name
InflaRX Investigational Site
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
InflaRX Investigational Site
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Facility Name
InflaRX Investigational Site
City
Łódź
ZIP/Postal Code
90-436
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34252397
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.
Results Reference
derived

Learn more about this trial

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

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