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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487276
Other study ID # IFX-1-P2.4
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 26, 2018
Est. completion date January 27, 2020

Study information

Verified date March 2021
Source InflaRx GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date January 27, 2020
Est. primary completion date May 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Placebo
Placebo

Locations

Country Name City State
Bulgaria InflaRX Investigational Site Sofia
Bulgaria InflaRX Investigational Site Sofia
Bulgaria InflaRX Investigational Site Stara Zagora
Canada InflaRX Investigational Site Peterborough Ontario
Canada InflaRX Investigational Site Richmond Hill Ontario
Canada InflaRX Investigational Site Saint John's Newfoundland and Labrador
Denmark InflaRX Investigational Site Copenhagen
Denmark InflaRX Investigational Site Roskilde
France InflaRX Investigational Site Antony Hauts De Seine
France InflaRX Investigational Site Bordeaux Gironde
France InflaRX Investigational Site Nantes Loire Atlantique
France InflaRX Investigational Site Nice Alpes Maritimes
France InflaRX Investigational Site Paris
France InflaRX Investigational Site Toulouse Haute Garonne
Germany InflaRX Investigational Site Bochum Nordrhein Westfalen
Germany InflaRX Investigational Site Darmstadt Hessen
Germany InflaRX Investigational Site Dessau Sachsen Anhalt
Germany InflaRX Investigational Site Frankfurt Hessen
Greece InflaRX Investigational Site Athens
Greece InflaRX Investigational Site Athens
Greece InflaRX Investigational Site Thessaloníki
Netherlands InflaRX Investigational Site Rotterdam
Poland InflaRX Investigational Site Gdansk
Poland InflaRX Investigational Site Klodzko
Poland InflaRX Investigational Site Kraków
Poland InflaRX Investigational Site Lódz
Poland InflaRX Investigational Site Wroclaw
Poland InflaRX Investigational Site Wroclaw
United States InflaRX Investigational Site Birmingham Alabama
United States InflaRX Investigational Site Chapel Hill North Carolina
United States InflaRX Investigational Site Cincinnati Ohio
United States InflaRX Investigational Site Columbia Missouri
United States InflaRX Investigational Site Dearborn Michigan
United States InflaRX Investigational Site Fort Myers Florida
United States InflaRx Investigational Site Goodlettsville Tennessee
United States InflaRX Investigational Site Hershey Pennsylvania
United States InflaRX Investigational Site Miami Florida
United States InflaRx Investigational Site Saint Joseph Missouri
United States InflaRX Investigational Site Saint Louis Missouri
United States InflaRX Investigational Site Saint Louis Missouri
United States InflaRX Investigational Site Sandy Springs Georgia

Sponsors (2)

Lead Sponsor Collaborator
InflaRx GmbH Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Greece,  Netherlands,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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