Trial record 1 of 6 for:
vilobelimab
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (SHINE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03487276 |
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Recruitment Status :
Completed
First Posted : April 4, 2018
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
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Sponsor:
InflaRx GmbH
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
InflaRx GmbH
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hidradenitis Suppurativa (HS) | Drug: IFX-1 Drug: Placebo | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 179 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 26, 2018 |
| Actual Primary Completion Date : | May 27, 2019 |
| Actual Study Completion Date : | January 27, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Cohort 1
Placebo
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Drug: Placebo
Placebo |
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Experimental: Cohort 2
Minimum Dose IFX-1 (400 mg Q4W)
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Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Names:
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Experimental: Cohort 3
Low dose IFX-1 (800 mg Q4W)
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Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Names:
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Experimental: Cohort 4
Medium Dose IFX-1 (800 mg Q2W)
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Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Names:
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Experimental: Cohort 5
High Dose IFX-1 (1200 mg Q2W)
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Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Names:
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Primary Outcome Measures :
- Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Day 1 until Day 309 ]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. [ Time Frame: From Day 1 until Day 309 ]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. [ Time Frame: From Day 1 until Day 309 ]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 [ Time Frame: From Day 1 until Day 309 ]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. [ Time Frame: From Day 1 until Day 309 ]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. [ Time Frame: From Day 1 until Day 309 ]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. [ Time Frame: From Day 1 until Day 309 ]The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487276
Locations
Show 41 study locations
Sponsors and Collaborators
InflaRx GmbH
Quintiles, Inc.
Investigators
| Study Director: | Othmar Zenker, CMO | InflaRx GmbH |
Study Documents (Full-Text)
Documents provided by InflaRx GmbH:
Documents provided by InflaRx GmbH:
Study Protocol and Statistical Analysis Plan [PDF] November 16, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | InflaRx GmbH |
| ClinicalTrials.gov Identifier: | NCT03487276 |
| Other Study ID Numbers: |
IFX-1-P2.4 |
| First Posted: | April 4, 2018 Key Record Dates |
| Results First Posted: | April 8, 2021 |
| Last Update Posted: | April 8, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by InflaRx GmbH:
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hidradenitis suppurativa monoclonal antibody complement factor C5a IFX-1 |
hidradenitis Suppurativa Clinical Response Inflammation skin diseases |
Additional relevant MeSH terms:
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Vilobelimab Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses |
Infections Skin Diseases, Infectious Suppuration Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |