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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Placebo Comparator | Placebo |
|
| Cohort 2 | Experimental | Minimum Dose IFX-1 (400 mg Q4W) |
|
| Cohort 3 | Experimental | Low dose IFX-1 (800 mg Q4W) |
|
| Cohort 4 | Experimental | Medium Dose IFX-1 (800 mg Q2W) |
|
| Cohort 5 | Experimental | High Dose IFX-1 (1200 mg Q2W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFX-1 | Drug | Single IV infusions of IFX-1 diluted in sodium chloride. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
History of heart disease or malignancy
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| Name | Affiliation | Role |
|---|---|---|
| Othmar Zenker, CMO | InflaRx GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InflaRX Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| InflaRX Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41081529 | Derived | Giamarellos-Bourboulis EJ, Jemec GBE, Prens EP, Riedemann NC, Otto I, Weisman J, Pulka G, Nowicki RJ, Kantardjiev V, Pinter A, Thomsen SF, Berneman D, Kanni T, Alavi A, Breno B, Gooderham M, Stone M, Anadkat MJ, Katoulis A, Papakonstantis M, Becherel PA, Szepietowski JC, van der Zee HH, Zouboulis CC, Sayed CJ. Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial. Br J Dermatol. 2026 Jan 27;194(2):254-263. doi: 10.1093/bjd/ljaf398. | |
| 34252397 |
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The study consisted of a Main and an Extension Period. In the Main Period 175 subjects were planned to be randomized to receive double-blind treatment with IMP or Placebo in 1 of 5 treatment cohorts in a ratio of 1:1:1:1:1. The Extension Period started after the Week 16 Visit. According to the assessed HiSCR response at Week 16, patients were distributed to two IFX-1 dosing regimens: Week 16 HiSCR responders to 800 mg Q4W and Week 16 HiSCR non-responders to 800 mg Q2W.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Placebo Placebo: Placebo |
| FG001 | Cohort 2 | Minimum Dose IFX-1 (400 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period (16 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2018 |
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| Placebo | Drug | Placebo |
|
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 |
| Fort Myers |
| Florida |
| 33912 |
| United States |
| InflaRX Investigational Site | Miami | Florida | 33136 | United States |
| InflaRX Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| InflaRX Investigational Site | Dearborn | Michigan | 48124 | United States |
| InflaRX Investigational Site | Columbia | Missouri | 65212 | United States |
| InflaRx Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| InflaRX Investigational Site | St Louis | Missouri | 63104 | United States |
| InflaRX Investigational Site | St Louis | Missouri | 63110 | United States |
| InflaRX Investigational Site | Chapel Hill | North Carolina | 27516 | United States |
| InflaRX Investigational Site | Cincinnati | Ohio | 45219 | United States |
| InflaRX Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| InflaRx Investigational Site | Goodlettsville | Tennessee | 37072 | United States |
| InflaRX Investigational Site | Sofia | 1431 | Bulgaria |
| InflaRX Investigational Site | Sofia | 1606 | Bulgaria |
| InflaRX Investigational Site | Stara Zagora | 6003 | Bulgaria |
| InflaRX Investigational Site | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| InflaRX Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| InflaRX Investigational Site | Richmond Hill | Ontario | L4C 9M7 | Canada |
| InflaRX Investigational Site | Copenhagen | 2400 | Denmark |
| InflaRX Investigational Site | Roskilde | 4000 | Denmark |
| InflaRX Investigational Site | Nice | Alpes Maritimes | 06202 | France |
| InflaRX Investigational Site | Bordeaux | Gironde | 33000 | France |
| InflaRX Investigational Site | Toulouse | Haute Garonne | 31059 | France |
| InflaRX Investigational Site | Antony | Hauts De Seine | 92160 | France |
| InflaRX Investigational Site | Nantes | Loire Atlantique | 44093 | France |
| InflaRX Investigational Site | Paris | 75475 | France |
| InflaRX Investigational Site | Darmstadt | Hesse | 64297 | Germany |
| InflaRX Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| InflaRX Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| InflaRX Investigational Site | Dessau | Saxony-Anhalt | 06847 | Germany |
| InflaRX Investigational Site | Athens | 115 25 | Greece |
| InflaRX Investigational Site | Athens | 12462 | Greece |
| InflaRX Investigational Site | Thessaloniki | 54645 | Greece |
| InflaRX Investigational Site | Rotterdam | 3015 CE | Netherlands |
| InflaRX Investigational Site | Gdansk | 80-402 | Poland |
| InflaRX Investigational Site | Krakow | 30-033 | Poland |
| InflaRX Investigational Site | KÅ‚odzko | 57-300 | Poland |
| InflaRX Investigational Site | Lodz | 90-436 | Poland |
| InflaRX Investigational Site | Wroclaw | 50-566 | Poland |
| InflaRX Investigational Site | Wroclaw | 51-318 | Poland |
| Derived |
| 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. |
| FG002 | Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| FG003 | Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| FG004 | Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Extension Period (28 Weeks) |
|
Baseline analysis performed for safety analysis set (SAS)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Placebo Placebo: Placebo |
| BG001 | Cohort 2 | Minimum Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| BG002 | Cohort 3 | Low dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| BG003 | Cohort 4 | Medium Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| BG004 | Cohort 5 | High Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Baseline AN (total abscess and inflammatory nodule) count | Median | Inter-Quartile Range | lesions |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was performed on the full analysis set (FAS) population | Posted | Count of Participants | Participants | 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. | Analysis was performed on the full analysis set (FAS) population. Only patients with non-missing assessment at Week 12 were analyzed. | Posted | Count of Participants | Participants | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Count of Participants | Participants | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Count of Participants | Participants | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Count of Participants | Participants | 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. | For the Main Period the full analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 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. | For the Main Period the safety analysis set was used for the analysis and results of Week 16 are displayed. For the Extension Period the safety analysis set was used for the analysis and results of week 44 are displayed. Only patients with non-missing assessment at the respective visit were analyzed. | Posted | Count of Participants | Participants | From Day 1 until Day 309 |
|
The observation period for Adverse Events (AEs) will start with confirmation of signed informed consent at Screening and ends at the Follow-up visit at Week 44.
The safety data were analyzed separately for the Main Period and the Extension Period. AEs assessed up to and including Week 16 Visit were attributed to the Main Period. All safety data assessed after IFX-1 infusion at Week 16 were attributed to the Extension Period. Analysis were performed in the safety analysis set consisting of 177 patients. Of the 179 randomized patients, only 177 received treatment with IMP as 2 patients withdrew from the study before they were treated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Period: Cohort 1 | Placebo Placebo: Placebo | 0 | 36 | 0 | 36 | 26 | 36 |
| EG001 | Main Period: Cohort 2 | Minimum Dose IFX-1 (400 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 34 | 0 | 34 | 26 | 34 |
| EG002 | Main Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 35 | 1 | 35 | 21 | 35 |
| EG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 36 | 2 | 36 | 24 | 36 |
| EG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 36 | 3 | 36 | 22 | 36 |
| EG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 72 | 2 | 72 | 34 | 72 |
| EG006 | Extension Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 0 | 84 | 3 | 84 | 49 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Korinna Pilz, MD, MSc | InflaRx N.V. | +49 89 414 189 78 00 | Korinna.Pilz@InflaRx.de |
| Jan 17, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D007249 | Inflammation |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706656 | vilobelimab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Netherlands |
|
| United States |
|
| Denmark |
|
| Poland |
|
| Bulgaria |
|
| France |
|
| Germany |
|
| HiSCR Non-responder |
|
| OG004 |
| Cohort 5 |
High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
| OG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
| OG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
| OG003 | Main Period: Cohort 4 | Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|
Medium Dose IFX-1 (800 mg Q2W)
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
| OG004 | Main Period: Cohort 5 | High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG005 | Extension Period: Cohort 3 | Low dose IFX-1 (800 mg Q4W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
| OG006 | Extension Period: Cohort 4 | Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. |
|
|