Hidradenitis Suppurativa (HS)
Conditions
Keywords
hidradenitis suppurativa, monoclonal antibody, complement factor C5a, IFX-1, hidradenitis Suppurativa Clinical Response, Inflammation, skin diseases
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.
Interventions
DRUGIFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
DRUGPlacebo
Placebo
Sponsors
Quintiles, Inc.
InflaRx GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Flares Relative to Day 1 | 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. | 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. | 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. |
| Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | 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. |
| Percentage of Patients Achieving NRS50. | 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. | 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. | 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. |
| Percentage of Patients Achieving NRS30 | 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. |
Countries
Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Placebo
Placebo: Placebo | 36 |
| Cohort 2 Minimum Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 34 |
| Cohort 3 Low dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 35 |
| Cohort 4 Medium Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 36 |
| Cohort 5 High Dose IFX-1
IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride. | 36 |
| Total | 177 |
Baseline characteristics
| Characteristic | Total | Cohort 5 | Cohort 4 | Cohort 1 | Cohort 3 | Cohort 2 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 174 Participants | 35 Participants | 36 Participants | 35 Participants | 35 Participants | 33 Participants |
| Age, Continuous | 36.0 years | 33.5 years | 37.0 years | 34.5 years | 35.0 years | 39.0 years |
| Baseline AN (total abscess and inflammatory nodule) count | 9.0 lesions | 12.5 lesions | 10.0 lesions | 9.5 lesions | 8.0 lesions | 9.0 lesions |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 170 Participants | 32 Participants | 35 Participants | 36 Participants | 34 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 152 Participants | 27 Participants | 32 Participants | 33 Participants | 29 Participants | 31 Participants |
| Region of Enrollment Bulgaria | 9 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Canada | 8 Participants | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Denmark | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants |
| Region of Enrollment France | 19 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Germany | 12 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment Greece | 47 Participants | 14 Participants | 10 Participants | 9 Participants | 9 Participants | 5 Participants |
| Region of Enrollment Netherlands | 6 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Poland | 38 Participants | 6 Participants | 8 Participants | 11 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 33 Participants | 7 Participants | 7 Participants | 4 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Female | 98 Participants | 23 Participants | 20 Participants | 21 Participants | 18 Participants | 16 Participants |
| Sex: Female, Male Male | 79 Participants | 13 Participants | 16 Participants | 15 Participants | 17 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 | 0 / 35 | 0 / 36 | 0 / 36 | 0 / 72 | 0 / 84 |
| other Total, other adverse events | 26 / 36 | 26 / 34 | 21 / 35 | 24 / 36 | 22 / 36 | 34 / 72 | 49 / 84 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 | 1 / 35 | 2 / 36 | 3 / 36 | 2 / 72 | 3 / 84 |
Outcome results
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.
Time frame: Week 16
Population: Analysis was performed on the full analysis set (FAS) population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Responder | 16 Participants |
| Cohort 1 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Non-responder | 18 Participants |
| Cohort 2 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Responder | 12 Participants |
| Cohort 2 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Non-responder | 18 Participants |
| Cohort 3 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Responder | 17 Participants |
| Cohort 3 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Non-responder | 16 Participants |
| Cohort 4 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Non-responder | 19 Participants |
| Cohort 4 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Responder | 12 Participants |
| Cohort 5 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Responder | 15 Participants |
| Cohort 5 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 | HiSCR Non-responder | 18 Participants |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -1.5 score on a scale | Standard Deviation 6.11 |
| Cohort 2 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | 0.6 score on a scale | Standard Deviation 6.39 |
| Cohort 3 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -2.6 score on a scale | Standard Deviation 7.19 |
| Cohort 4 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -5.0 score on a scale | Standard Deviation 5.9 |
| Cohort 5 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -2.4 score on a scale | Standard Deviation 5.24 |
| Extension Period: Cohort 3 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -1.5 score on a scale | Standard Deviation 7.18 |
| Extension Period: Cohort 4 | Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. | -2.0 score on a scale | Standard Deviation 6.52 |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -16.4 score on a scale | Standard Deviation 30.78 |
| Cohort 2 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -17.5 score on a scale | Standard Deviation 48.43 |
| Cohort 3 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -29.4 score on a scale | Standard Deviation 32.35 |
| Cohort 4 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -22.9 score on a scale | Standard Deviation 52 |
| Cohort 5 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -35.2 score on a scale | Standard Deviation 101.91 |
| Extension Period: Cohort 3 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -47.9 score on a scale | Standard Deviation 70.87 |
| Extension Period: Cohort 4 | Absolute Change in Modified Sartorius Score (mSS) From Day 1. | -27.5 score on a scale | Standard Deviation 45.02 |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -1.2 score on a scale | Standard Deviation 2.82 |
| Cohort 2 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -0.1 score on a scale | Standard Deviation 2.68 |
| Cohort 3 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -0.7 score on a scale | Standard Deviation 2.37 |
| Cohort 4 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -1.5 score on a scale | Standard Deviation 2.92 |
| Cohort 5 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -1.8 score on a scale | Standard Deviation 3.03 |
| Extension Period: Cohort 3 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -1.5 score on a scale | Standard Deviation 2.94 |
| Extension Period: Cohort 4 | Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. | -1.3 score on a scale | Standard Deviation 2.52 |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 6 Participants |
| Cohort 1 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 28 Participants |
| Cohort 2 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 3 Participants |
| Cohort 2 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 27 Participants |
| Cohort 3 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 1 Participants |
| Cohort 3 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 31 Participants |
| Cohort 4 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 0 Participants |
| Cohort 4 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 30 Participants |
| Cohort 5 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 1 Participants |
| Cohort 5 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 31 Participants |
| Extension Period: Cohort 3 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 3 Participants |
| Extension Period: Cohort 3 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 64 Participants |
| Extension Period: Cohort 4 | Number of Patients With Flares Relative to Day 1 | Patient with flares | 5 Participants |
| Extension Period: Cohort 4 | Number of Patients With Flares Relative to Day 1 | Patient without flares | 47 Participants |
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.
Time frame: Week 12
Population: Analysis was performed on the full analysis set (FAS) population. Only patients with non-missing assessment at Week 12 were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Responder | 14 Participants |
| Cohort 1 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Non-responder | 20 Participants |
| Cohort 2 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Responder | 14 Participants |
| Cohort 2 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Non-responder | 17 Participants |
| Cohort 3 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Responder | 12 Participants |
| Cohort 3 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Non-responder | 21 Participants |
| Cohort 4 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Non-responder | 19 Participants |
| Cohort 4 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Responder | 13 Participants |
| Cohort 5 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Responder | 13 Participants |
| Cohort 5 | Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 | HiSCR Non-responder | 19 Participants |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Percentage of Patients Achieving NRS30 | 7 Participants |
| Cohort 2 | Percentage of Patients Achieving NRS30 | 6 Participants |
| Cohort 3 | Percentage of Patients Achieving NRS30 | 5 Participants |
| Cohort 4 | Percentage of Patients Achieving NRS30 | 9 Participants |
| Cohort 5 | Percentage of Patients Achieving NRS30 | 8 Participants |
| Extension Period: Cohort 3 | Percentage of Patients Achieving NRS30 | 12 Participants |
| Extension Period: Cohort 4 | Percentage of Patients Achieving NRS30 | 10 Participants |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Percentage of Patients Achieving NRS50. | 6 Participants |
| Cohort 2 | Percentage of Patients Achieving NRS50. | 3 Participants |
| Cohort 3 | Percentage of Patients Achieving NRS50. | 2 Participants |
| Cohort 4 | Percentage of Patients Achieving NRS50. | 7 Participants |
| Cohort 5 | Percentage of Patients Achieving NRS50. | 5 Participants |
| Extension Period: Cohort 3 | Percentage of Patients Achieving NRS50. | 7 Participants |
| Extension Period: Cohort 4 | Percentage of Patients Achieving NRS50. | 5 Participants |
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.
Time frame: From Day 1 until Day 309
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Safety Parameters (Adverse Events) Will be Assessed. | 26 Participants |
| Cohort 2 | Safety Parameters (Adverse Events) Will be Assessed. | 26 Participants |
| Cohort 3 | Safety Parameters (Adverse Events) Will be Assessed. | 21 Participants |
| Cohort 4 | Safety Parameters (Adverse Events) Will be Assessed. | 24 Participants |
| Cohort 5 | Safety Parameters (Adverse Events) Will be Assessed. | 22 Participants |
| Extension Period: Cohort 3 | Safety Parameters (Adverse Events) Will be Assessed. | 39 Participants |
| Extension Period: Cohort 4 | Safety Parameters (Adverse Events) Will be Assessed. | 49 Participants |