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

• Sponsor: InflaRx GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03487276
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 179
• Locations: 41
• Arms: 5
• Actual Duration (Months): 23
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa (HS)	Drug: IFX-1; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• 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: Feb 26, 2018
• Actual Primary Completion Date: May 27, 2019
• Actual Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Cohort 1 Placebo	Drug: Placebo; Placebo
Experimental: Cohort 2 Minimum Dose IFX-1 (400 mg Q4W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29 Vilobelimab
Experimental: Cohort 3 Low dose IFX-1 (800 mg Q4W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29 Vilobelimab
Experimental: Cohort 4 Medium Dose IFX-1 (800 mg Q2W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29 Vilobelimab
Experimental: Cohort 5 High Dose IFX-1 (1200 mg Q2W)	Drug: IFX-1; Single IV infusions of IFX-1 diluted in sodium chloride.; Other Names: CaCP29 Vilobelimab

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	InflaRX Investigational Site	Birmingham	Alabama	United States	35233
2	InflaRX Investigational Site	Fort Myers	Florida	United States	33912
3	InflaRX Investigational Site	Miami	Florida	United States	33136
4	InflaRX Investigational Site	Sandy Springs	Georgia	United States	30328
5	InflaRX Investigational Site	Dearborn	Michigan	United States	48124
6	InflaRX Investigational Site	Columbia	Missouri	United States	65212
7	InflaRx Investigational Site	Saint Joseph	Missouri	United States	64506
8	InflaRX Investigational Site	Saint Louis	Missouri	United States	63104
9	InflaRX Investigational Site	Saint Louis	Missouri	United States	63110
10	InflaRX Investigational Site	Chapel Hill	North Carolina	United States	27516
11	InflaRX Investigational Site	Cincinnati	Ohio	United States	45219
12	InflaRX Investigational Site	Hershey	Pennsylvania	United States	17033
13	InflaRx Investigational Site	Goodlettsville	Tennessee	United States	37072
14	InflaRX Investigational Site	Sofia		Bulgaria	1431
15	InflaRX Investigational Site	Sofia		Bulgaria	1606
16	InflaRX Investigational Site	Stara Zagora		Bulgaria	6003
17	InflaRX Investigational Site	Saint John's	Newfoundland and Labrador	Canada	A1C 2H5
18	InflaRX Investigational Site	Peterborough	Ontario	Canada	K9J 5K2
19	InflaRX Investigational Site	Richmond Hill	Ontario	Canada	L4C 9M7
20	InflaRX Investigational Site	Copenhagen		Denmark	2400
21	InflaRX Investigational Site	Roskilde		Denmark	4000
22	InflaRX Investigational Site	Nice	Alpes Maritimes	France	06202
23	InflaRX Investigational Site	Bordeaux	Gironde	France	33000
24	InflaRX Investigational Site	Toulouse	Haute Garonne	France	31059
25	InflaRX Investigational Site	Antony	Hauts De Seine	France	92160
26	InflaRX Investigational Site	Nantes	Loire Atlantique	France	44093
27	InflaRX Investigational Site	Paris		France	75475
28	InflaRX Investigational Site	Darmstadt	Hessen	Germany	64297
29	InflaRX Investigational Site	Frankfurt	Hessen	Germany	60590
30	InflaRX Investigational Site	Bochum	Nordrhein Westfalen	Germany	44791
31	InflaRX Investigational Site	Dessau	Sachsen Anhalt	Germany	06847
32	InflaRX Investigational Site	Athens		Greece	115 25
33	InflaRX Investigational Site	Athens		Greece	12462
34	InflaRX Investigational Site	Thessaloníki		Greece	54645
35	InflaRX Investigational Site	Rotterdam		Netherlands	3015 CE
36	InflaRX Investigational Site	Gdańsk		Poland	80-402
37	InflaRX Investigational Site	Kraków		Poland	30-033
38	InflaRX Investigational Site	Kłodzko		Poland	57-300
39	InflaRX Investigational Site	Wrocław		Poland	50-566
40	InflaRX Investigational Site	Wrocław		Poland	51-318
41	InflaRX Investigational Site	Łódź		Poland	90-436

Sponsors and Collaborators

• InflaRx GmbH
• Quintiles, Inc.

Investigators

• Study Director: Othmar Zenker, CMO, InflaRx GmbH

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 16, 2018

More Information

Publications

None provided.

• Responsible Party: InflaRx GmbH
• ClinicalTrials.gov Identifier: NCT03487276
• Other Study ID Numbers: IFX-1-P2.4
• First Posted: Apr 4, 2018
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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: hidradenitis suppurativa; monoclonal antibody; complement factor C5a; IFX-1; hidradenitis Suppurativa Clinical Response; Inflammation; skin diseases
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Vilobelimab

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Period Title: Main Period (16 Weeks)
STARTED	37	34	36	36	36
COMPLETED	34	30	32	30	31
NOT COMPLETED	3	4	4	6	5
Period Title: Main Period (16 Weeks)
STARTED	0	0	72	84	0
Number of Patients in Cohort 1 (Main Period) Crossed Over to Cohort 3 or 4	0	0	16	18	0
Number of Patients in Cohort 2 (Main Period) Crossed Over to Cohort 3 or 4	0	0	12	18	0
Number of Patients in Cohort 3 (Main Period) Crossed Over to Cohort 3 or 4	0	0	17	15	0
Number of Patients in Cohort 4 (Main Period) Crossed Over to Cohort 3 or 4	0	0	12	18	0
Number of Patients in Cohort 5 (Main Period) Crossed Over to Cohort 3 or 4	0	0	15	16	0
COMPLETED	0	0	67	54	0
NOT COMPLETED	0	0	5	30	0

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	Low dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	Medium Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	Total of all reporting groups
Overall Participants	36	34	35	36	36	177
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	35 97.2%	33 97.1%	35 100%	36 100%	35 97.2%	174 98.3%
>=65 years	1 2.8%	1 2.9%	0 0%	0 0%	1 2.8%	3 1.7%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	34.5	39.0	35.0	37.0	33.5	36.0
Sex: Female, Male (Count of Participants)
Female	21 58.3%	16 47.1%	18 51.4%	20 55.6%	23 63.9%	98 55.4%
Male	15 41.7%	18 52.9%	17 48.6%	16 44.4%	13 36.1%	79 44.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 2.9%	1 2.9%	1 2.8%	4 11.1%	7 4%
Not Hispanic or Latino	36 100%	33 97.1%	34 97.1%	35 97.2%	32 88.9%	170 96%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	1 2.8%	1 0.6%
Asian	0 0%	1 2.9%	0 0%	0 0%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 8.3%	2 5.9%	4 11.4%	4 11.1%	4 11.1%	17 9.6%
White	33 91.7%	31 91.2%	29 82.9%	32 88.9%	27 75%	152 85.9%
More than one race	0 0%	0 0%	1 2.9%	0 0%	1 2.8%	2 1.1%
Unknown or Not Reported	0 0%	0 0%	1 2.9%	0 0%	3 8.3%	4 2.3%
Region of Enrollment (Count of Participants)
Greece	9 25%	5 14.7%	9 25.7%	10 27.8%	14 38.9%	47 26.6%
Canada	1 2.8%	0 0%	2 5.7%	4 11.1%	1 2.8%	8 4.5%
Netherlands	2 5.6%	0 0%	1 2.9%	1 2.8%	2 5.6%	6 3.4%
United States	4 11.1%	7 20.6%	8 22.9%	7 19.4%	7 19.4%	33 18.6%
Denmark	2 5.6%	2 5.9%	1 2.9%	0 0%	0 0%	5 2.8%
Poland	11 30.6%	9 26.5%	4 11.4%	8 22.2%	6 16.7%	38 21.5%
Bulgaria	2 5.6%	4 11.8%	2 5.7%	1 2.8%	0 0%	9 5.1%
France	4 11.1%	3 8.8%	5 14.3%	3 8.3%	4 11.1%	19 10.7%
Germany	1 2.8%	4 11.8%	3 8.6%	2 5.6%	2 5.6%	12 6.8%
Baseline AN (total abscess and inflammatory nodule) count (lesions) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [lesions]	9.5	9.0	8.0	10.0	12.5	9.0

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis was performed on the full analysis set (FAS) population

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	34	30	33	31	33
HiSCR Responder	16 44.4%	12 35.3%	17 48.6%	12 33.3%	15 41.7%
HiSCR Non-responder	18 50%	18 52.9%	16 45.7%	19 52.8%	18 50%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis was performed on the full analysis set (FAS) population. Only patients with non-missing assessment at Week 12 were analyzed.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	34	31	33	32	32
HiSCR Responder	14 38.9%	14 41.2%	12 34.3%	13 36.1%	13 36.1%
HiSCR Non-responder	20 55.6%	17 50%	21 60%	19 52.8%	19 52.8%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	34	30	32	30	32	67	52
Patient with flares	6 16.7%	3 8.8%	1 2.9%	0 0%	1 2.8%	3 1.7%	5 NaN
Patient without flares	28 77.8%	27 79.4%	31 88.6%	30 83.3%	31 86.1%	64 36.2%	47 NaN

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	33	28	30	28	31	64	49
Mean (Standard Deviation) [score on a scale]	-16.4 (30.78)	-17.5 (48.43)	-29.4 (32.35)	-22.9 (52.00)	-35.2 (101.91)	-47.9 (70.87)	-27.5 (45.02)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	29	23	24	22	21	32	28
Mean (Standard Deviation) [score on a scale]	-1.2 (2.82)	-0.1 (2.68)	-0.7 (2.37)	-1.5 (2.92)	-1.8 (3.03)	-1.5 (2.94)	-1.3 (2.52)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	28	22	23	22	21	30	28
Count of Participants [Participants]	7 19.4%	6 17.6%	5 14.3%	9 25%	8 22.2%	12 6.8%	10 NaN

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	28	22	23	22	21	30	28
Count of Participants [Participants]	6 16.7%	3 8.8%	2 5.7%	7 19.4%	5 13.9%	7 4%	5 NaN

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	32	30	30	28	32	59	48
Mean (Standard Deviation) [score on a scale]	-1.5 (6.11)	0.6 (6.39)	-2.6 (7.19)	-5.0 (5.90)	-2.4 (5.24)	-1.5 (7.18)	-2.0 (6.52)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Main Period: Cohort 1	Main Period: Cohort 2	Main Period: Cohort 3	Main Period: Cohort 4	Main Period: Cohort 5	Extension Period: Cohort 3	Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo	Minimum Dose IFX-1 (400 mg Q4W) 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.	Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.	High Dose IFX-1 (1200 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.	Low dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
Measure Participants	36	34	35	36	36	72	84
Count of Participants [Participants]	26 72.2%	26 76.5%	21 60%	24 66.7%	22 61.1%	39 22%	49 NaN

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Main Period: Cohort 1		Main Period: Cohort 2		Main Period: Cohort 3		Main Period: Cohort 4		Main Period: Cohort 5		Extension Period: Cohort 3		Extension Period: Cohort 4
Arm/Group Description	Placebo Placebo: Placebo		Minimum Dose IFX-1 (400 mg Q4W) 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.		Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.		High Dose IFX-1 (1200 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.		Medium Dose IFX-1 (800 mg Q2W) IFX-1: Single IV infusions of IFX-1 diluted in sodium chloride.
All Cause Mortality
	Main Period: Cohort 1		Main Period: Cohort 2		Main Period: Cohort 3		Main Period: Cohort 4		Main Period: Cohort 5		Extension Period: Cohort 3		Extension Period: Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Serious Adverse Events
	Main Period: Cohort 1		Main Period: Cohort 2		Main Period: Cohort 3		Main Period: Cohort 4		Main Period: Cohort 5		Extension Period: Cohort 3		Extension Period: Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/34 (0%)		1/35 (2.9%)		2/36 (5.6%)		3/36 (8.3%)		2/72 (2.8%)		3/84 (3.6%)
Hepatobiliary disorders
Bile duct stone	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
Infections and infestations
Abscess bacterial	0/36 (0%)		0/34 (0%)		0/35 (0%)		1/36 (2.8%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Pneumonia	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		1/36 (2.8%)		0/72 (0%)		0/84 (0%)
Sepsis	0/36 (0%)		0/34 (0%)		0/35 (0%)		1/36 (2.8%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Cholangitis infective	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
Influenza	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		1/84 (1.2%)
Injury, poisoning and procedural complications
Femoral neck fracture	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
Musculoskeletal and connective tissue disorders
Bursitis	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		1/84 (1.2%)
Nervous system disorders
Sciatica	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		1/36 (2.8%)		0/72 (0%)		0/84 (0%)
Dyspnoea	0/36 (0%)		0/34 (0%)		1/35 (2.9%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Asthma	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
Skin and subcutaneous tissue disorders
Hidradenitis	0/36 (0%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		1/36 (2.8%)		0/72 (0%)		2/84 (2.4%)
Other (Not Including Serious) Adverse Events
	Main Period: Cohort 1		Main Period: Cohort 2		Main Period: Cohort 3		Main Period: Cohort 4		Main Period: Cohort 5		Extension Period: Cohort 3		Extension Period: Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/36 (72.2%)		26/34 (76.5%)		21/35 (60%)		24/36 (66.7%)		22/36 (61.1%)		34/72 (47.2%)		49/84 (58.3%)
Gastrointestinal disorders
Diarrhoea	0/36 (0%)		4/34 (11.8%)		2/35 (5.7%)		3/36 (8.3%)		1/36 (2.8%)		2/72 (2.8%)		2/84 (2.4%)
Nausea	2/36 (5.6%)		2/34 (5.9%)		1/35 (2.9%)		1/36 (2.8%)		2/36 (5.6%)		0/72 (0%)		2/84 (2.4%)
Dyspepsia	0/36 (0%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		1/84 (1.2%)
Gastrooesophageal reflux disease	2/36 (5.6%)		1/34 (2.9%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		1/84 (1.2%)
Vomiting	0/36 (0%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		0/84 (0%)
General disorders
Fatigue	2/36 (5.6%)		0/34 (0%)		3/35 (8.6%)		2/36 (5.6%)		3/36 (8.3%)		0/72 (0%)		1/84 (1.2%)
Pyrexia	1/36 (2.8%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		2/36 (5.6%)		2/72 (2.8%)		0/84 (0%)
Pain	0/36 (0%)		0/34 (0%)		0/35 (0%)		1/36 (2.8%)		2/36 (5.6%)		0/72 (0%)		0/84 (0%)
Immune system disorders
Gastroenteritis	1/36 (2.8%)		0/34 (0%)		0/35 (0%)		2/36 (5.6%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Infections and infestations
Nasopharyngitis	6/36 (16.7%)		4/34 (11.8%)		6/35 (17.1%)		4/36 (11.1%)		3/36 (8.3%)		4/72 (5.6%)		8/84 (9.5%)
Influenza	2/36 (5.6%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		3/36 (8.3%)		2/72 (2.8%)		2/84 (2.4%)
Pharyngitis	2/36 (5.6%)		1/34 (2.9%)		1/35 (2.9%)		0/36 (0%)		1/36 (2.8%)		2/72 (2.8%)		2/84 (2.4%)
Sinusitis	0/36 (0%)		0/34 (0%)		2/35 (5.7%)		1/36 (2.8%)		1/36 (2.8%)		1/72 (1.4%)		0/84 (0%)
Abscess	0/36 (0%)		1/34 (2.9%)		2/35 (5.7%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Bronchitis	2/36 (5.6%)		1/34 (2.9%)		1/35 (2.9%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Cellulitis	0/36 (0%)		0/34 (0%)		0/35 (0%)		2/36 (5.6%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Viral upper respiratory tract infection	0/36 (0%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Vulvovaginal candidiasis	2/36 (5.6%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		3/84 (3.6%)
Upper respiratory tract infection	1/36 (2.8%)		1/34 (2.9%)		1/35 (2.9%)		0/36 (0%)		1/36 (2.8%)		1/72 (1.4%)		4/84 (4.8%)
Injury, poisoning and procedural complications
Foot fracture	0/36 (0%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		0/72 (0%)		0/84 (0%)
Ligament sprain	1/36 (2.8%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		4/84 (4.8%)
Investigations
International normalised ratio increased	2/36 (5.6%)		0/34 (0%)		0/35 (0%)		0/36 (0%)		2/36 (5.6%)		1/72 (1.4%)		3/84 (3.6%)
Musculoskeletal and connective tissue disorders
Back pain	1/36 (2.8%)		1/34 (2.9%)		0/35 (0%)		2/36 (5.6%)		0/36 (0%)		0/72 (0%)		1/84 (1.2%)
Pain in extremity	1/36 (2.8%)		2/34 (5.9%)		0/35 (0%)		0/36 (0%)		1/36 (2.8%)		0/72 (0%)		0/84 (0%)
Arthralgia	1/36 (2.8%)		0/34 (0%)		0/35 (0%)		2/36 (5.6%)		0/36 (0%)		0/72 (0%)		1/84 (1.2%)
Nervous system disorders
Headache	6/36 (16.7%)		4/34 (11.8%)		0/35 (0%)		4/36 (11.1%)		5/36 (13.9%)		4/72 (5.6%)		6/84 (7.1%)
Syncope	0/36 (0%)		0/34 (0%)		0/35 (0%)		2/36 (5.6%)		1/36 (2.8%)		1/72 (1.4%)		0/84 (0%)
Presyncope	0/36 (0%)		0/34 (0%)		2/35 (5.7%)		0/36 (0%)		1/36 (2.8%)		0/72 (0%)		0/84 (0%)
Skin and subcutaneous tissue disorders
Hidradenitis	5/36 (13.9%)		4/34 (11.8%)		2/35 (5.7%)		7/36 (19.4%)		6/36 (16.7%)		8/72 (11.1%)		10/84 (11.9%)
Pain of skin	0/36 (0%)		3/34 (8.8%)		1/35 (2.9%)		0/36 (0%)		0/36 (0%)		1/72 (1.4%)		1/84 (1.2%)
Vascular disorders
Hypertension	0/36 (0%)		0/34 (0%)		0/35 (0%)		2/36 (5.6%)		1/36 (2.8%)		2/72 (2.8%)		1/84 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.