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CompletedNCT03487276SHINEUpdated Apr 8, 2021Results posted

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

A Phase 2 interventional study of IFX-1 and Placebo in Hidradenitis Suppurativa (HS), sponsored by InflaRx GmbH. Completed at 41 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)

Keywords

  • hidradenitis suppurativa
  • monoclonal antibody
  • complement factor C5a
  • IFX-1
  • hidradenitis Suppurativa Clinical Response
  • Inflammation
  • skin diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
179 participants (actual)

Study arms

  • Placebo comparator
    Cohort 1

    Placebo

    Drug: Placebo

  • Experimental
    Cohort 2

    Minimum Dose IFX-1 (400 mg Q4W)

    Drug: IFX-1

  • Experimental
    Cohort 3

    Low dose IFX-1 (800 mg Q4W)

    Drug: IFX-1

  • Experimental
    Cohort 4

    Medium Dose IFX-1 (800 mg Q2W)

    Drug: IFX-1

  • Experimental
    Cohort 5

    High Dose IFX-1 (1200 mg Q2W)

    Drug: IFX-1

Interventions

  • DrugIFX-1

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

    Also known as: CaCP29, Vilobelimab

  • DrugPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

06

Results

Posted Apr 8, 2021

Participant flow

Main Period (16 Weeks)
Participant flow — Main Period (16 Weeks)
MilestoneCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Started3734363636
Completed3430323031
Not completed34465
Extension Period (28 Weeks)
Participant flow — Extension Period (28 Weeks)
MilestoneCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Started0072840
Number of patients in cohort 1 (main period) crossed over to cohort 3 or 40016180
Number of patients in cohort 2 (main period) crossed over to cohort 3 or 40012180
Number of patients in cohort 3 (main period) crossed over to cohort 3 or 40017150
Number of patients in cohort 4 (main period) crossed over to cohort 3 or 40012180
Number of patients in cohort 5 (main period) crossed over to cohort 3 or 40015160
Completed0067540
Not completed005300

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
ParticipantsCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
HiSCR Responder1612171215
HiSCR Non-responder1818161918
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
ParticipantsCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
HiSCR Responder1414121313
HiSCR Non-responder2017211919
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Flares Relative to Day 1
ParticipantsMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Patient with flares6310135
Patient without flares28273130316447
SecondaryAbsolute 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
Reported as:
Mean · score on a scale
Absolute Change in Modified Sartorius Score (mSS) From Day 1.
score on a scaleMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Absolute Change in Modified Sartorius Score (mSS) From Day 1.-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
SecondaryAbsolute 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
Reported as:
Mean · score on a scale
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
score on a scaleMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.-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
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients Achieving NRS30
ParticipantsMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Percentage of Patients Achieving NRS30765981210
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients Achieving NRS50.
ParticipantsMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Percentage of Patients Achieving NRS50.6327575
SecondaryAbsolute 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
Reported as:
Mean · score on a scale
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
score on a scaleMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.-1.5 ± 6.110.6 ± 6.39-2.6 ± 7.19-5.0 ± 5.90-2.4 ± 5.24-1.5 ± 7.18-2.0 ± 6.52
SecondarySafety 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
Reported as:
Count of participants · Participants
Safety Parameters (Adverse Events) Will be Assessed.
ParticipantsMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
Safety Parameters (Adverse Events) Will be Assessed.26262124223949

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Main Period: Cohort 10/36 (0%)0/36 (0%)26/36 (72.2%)
Main Period: Cohort 20/34 (0%)0/34 (0%)26/34 (76.5%)
Main Period: Cohort 30/35 (0%)1/35 (2.9%)21/35 (60%)
Main Period: Cohort 40/36 (0%)2/36 (5.6%)24/36 (66.7%)
Main Period: Cohort 50/36 (0%)3/36 (8.3%)22/36 (61.1%)
Extension Period: Cohort 30/72 (0%)2/72 (2.8%)34/72 (47.2%)
Extension Period: Cohort 40/84 (0%)3/84 (3.6%)49/84 (58.3%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
DyspnoeaRespiratory, thoracic and mediastinal disorders0/360/341/350/360/360/720/84
Abscess bacterialInfections and infestations0/360/340/351/360/360/720/84
PneumoniaInfections and infestations0/360/340/350/361/360/720/84
SepsisInfections and infestations0/360/340/351/360/360/720/84
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/360/340/350/361/360/720/84
HidradenitisSkin and subcutaneous tissue disorders0/360/340/350/361/360/722/84
Bile duct stoneHepatobiliary disorders0/360/340/350/360/361/720/84
Cholangitis infectiveInfections and infestations0/360/340/350/360/361/720/84
Femoral neck fractureInjury, poisoning and procedural complications0/360/340/350/360/361/720/84
SciaticaNervous system disorders0/360/340/350/360/361/720/84
Most frequent other events
Showing 10 of 31
Most frequent other events
EventMain Period: Cohort 1Main Period: Cohort 2Main Period: Cohort 3Main Period: Cohort 4Main Period: Cohort 5Extension Period: Cohort 3Extension Period: Cohort 4
HidradenitisSkin and subcutaneous tissue disorders5/364/342/357/366/368/7210/84
NasopharyngitisInfections and infestations6/364/346/354/363/364/728/84
HeadacheNervous system disorders6/364/340/354/365/364/726/84
DiarrhoeaGastrointestinal disorders0/364/342/353/361/362/722/84
Pain of skinSkin and subcutaneous tissue disorders0/363/341/350/360/361/721/84
FatigueGeneral disorders2/360/343/352/363/360/721/84
InfluenzaInfections and infestations2/360/340/350/363/362/722/84
NauseaGastrointestinal disorders2/362/341/351/362/360/722/84
Viral upper respiratory tract infectionInfections and infestations0/362/340/350/360/360/720/84
PyrexiaGeneral disorders1/362/340/350/362/362/720/84

Baseline characteristics

Baseline analysis performed for safety analysis set (SAS)

Age, Categorical
Age, Categorical(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
<=18 years000000
Between 18 and 65 years3533353635174
>=65 years110013
Age, Continuous
Age, Continuous(years)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Median34.5 (27.0 to 42.5)39.0 (33.0 to 45.0)35.0 (25.0 to 46.0)37.0 (31.0 to 46.0)33.5 (27.5 to 41.0)36.0 (29.0 to 45.0)
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Female211618202398
Male151817161379
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Hispanic or Latino011147
Not Hispanic or Latino3633343532170
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
American Indian or Alaska Native000011
Asian010001
Native Hawaiian or Other Pacific Islander000000
Black or African American3244417
White3331293227152
More than one race001012
Unknown or Not Reported001034
Region of Enrollment
Region of Enrollment(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Greece959101447
Canada102418
Netherlands201126
United States4787733
Denmark221005
Poland11948638
Bulgaria242109
France4353419
Germany1432212
Baseline AN (total abscess and inflammatory nodule) count
Baseline AN (total abscess and inflammatory nodule) count(lesions)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Median9.5 (5.0 to 15.0)9.0 (6.0 to 15.0)8.0 (7.0 to 17.0)10.0 (6.0 to 16.0)12.5 (5.5 to 15.5)9.0 (6.0 to 16.0)
07

Study locations

41 sites
  • InflaRX Investigational Site
    Birmingham, Alabama 35233, United States
  • InflaRX Investigational Site
    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
    Saint Louis, Missouri 63104, United States
  • InflaRX Investigational Site
    Saint 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
    Saint 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, Hessen 64297, Germany
  • InflaRX Investigational Site
    Frankfurt, Hessen 60590, Germany
  • InflaRX Investigational Site
    Bochum, Nordrhein Westfalen 44791, Germany
  • InflaRX Investigational Site
    Dessau, Sachsen Anhalt 06847, Germany
  • InflaRX Investigational Site
    Athens, 115 25, Greece
  • InflaRX Investigational Site
    Athens, 12462, Greece
  • InflaRX Investigational Site
    Thessaloníki, 54645, Greece
  • InflaRX Investigational Site
    Rotterdam, 3015 CE, Netherlands
  • InflaRX Investigational Site
    Gdańsk, 80-402, Poland
  • InflaRX Investigational Site
    Kraków, 30-033, Poland
  • InflaRX Investigational Site
    Kłodzko, 57-300, Poland
  • InflaRX Investigational Site
    Wrocław, 50-566, Poland
  • InflaRX Investigational Site
    Wrocław, 51-318, Poland
  • InflaRX Investigational Site
    Łódź, 90-436, Poland
08

References and documents

Publications

  • 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. PubMed 34252397 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 16, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03487276
Lead sponsor
InflaRx GmbH
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Feb 26, 2018
Primary completion
May 27, 2019
Completion
Jan 27, 2020
Results posted
Apr 8, 2021
Last update
Apr 8, 2021

Study contacts

Othmar Zenker, CMO
study director · InflaRx GmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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