Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
IFX-1
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
- Male or female patients ≥ 18 years old
- Written informed consent
- Diagnosis of HS for at least 1 year
- Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of which is Hurley Stage II or III
- Total AN (abscesses and nodules) count ≥3
- Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals
- Failure of previous antimicrobial treatments
Exclusion Criteria:
- Body weight above 150 kg or body weight below 60 kg
- Has a draining fistula count of greater than 30 at baseline
- Surgical management planned within the next 24 weeks
- Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days
Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
- Active infection
- Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
- Depression
- History of systemic lupus erythematosus or rheumatoid arthritis
- Any immunodeficiency disease
- Active hematological or solid malignant tumor
- Patients must not have had any other active skin disease or condition (e.g., bacterial, fungal, or viral infection) that may have interfered with assessment of HS.
One of the following abnormal laboratory results
- White blood cell count < 2,500/mm3
- Neutrophil count < 1000/mm3
- Serum Creatinine > 3 x Upper Normal Limit (UNL)
- Total Bilirubin > 2 x UNL
- Alanine-Aminotransferase (ALAT) > 2 x UNL
- Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
- Prior administration of any biological compound in the last 3 months
- Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
- Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)
General exclusion criteria
- Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
- Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
- Participation in any interventional clinical trial within the last three months
- Known intravenous drug abuse
- Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
Sites / Locations
- ATTIKON University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
IFX-1
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
Secondary Outcome Measures
Plasma concentration of IFX-1
Plasma concentration of C5a
Percentage change from baseline in total abscess and nodule (AN) count per time point
Hidradenitis Suppurativa Clinical Response (HiSCR) per time point
Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline
HS-PGA score per time point
Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm
VAS pain score per time point
Change from baseline in VAS pain score per time point
VAS disease score per time
Change from baseline in VAS disease score per time point
Dermatology Life Quality Index (DLQI) per time point
Change from baseline in DLQI per time point
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03001622
Brief Title
Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
Official Title
An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InflaRx GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFX-1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
IFX-1
Intervention Description
chimeric, monoclonal antibody
Primary Outcome Measure Information:
Title
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
Time Frame
up to Day 134
Title
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
Time Frame
up to Day 134
Secondary Outcome Measure Information:
Title
Plasma concentration of IFX-1
Time Frame
From Day 1 until Day 134
Title
Plasma concentration of C5a
Time Frame
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Title
Percentage change from baseline in total abscess and nodule (AN) count per time point
Time Frame
Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Title
Hidradenitis Suppurativa Clinical Response (HiSCR) per time point
Time Frame
Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Title
Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline
Time Frame
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Title
HS-PGA score per time point
Time Frame
Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Title
Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm
Time Frame
At each visit from Day 1 until Day 134
Title
VAS pain score per time point
Time Frame
At each visit from Day 1 until Day 134
Title
Change from baseline in VAS pain score per time point
Time Frame
At each visit from Day 1 until Day 134
Title
VAS disease score per time
Time Frame
At each visit from Day 1 until Day 134
Title
Change from baseline in VAS disease score per time point
Time Frame
At each visit from Day 1 until Day 134
Title
Dermatology Life Quality Index (DLQI) per time point
Time Frame
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Title
Change from baseline in DLQI per time point
Time Frame
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥ 18 years old
Written informed consent
Diagnosis of HS for at least 1 year
Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of which is Hurley Stage II or III
Total AN (abscesses and nodules) count ≥3
Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals
Failure of previous antimicrobial treatments
Exclusion Criteria:
Body weight above 150 kg or body weight below 60 kg
Has a draining fistula count of greater than 30 at baseline
Surgical management planned within the next 24 weeks
Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days
Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
Active infection
Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
Depression
History of systemic lupus erythematosus or rheumatoid arthritis
Any immunodeficiency disease
Active hematological or solid malignant tumor
Patients must not have had any other active skin disease or condition (e.g., bacterial, fungal, or viral infection) that may have interfered with assessment of HS.
One of the following abnormal laboratory results
White blood cell count < 2,500/mm3
Neutrophil count < 1000/mm3
Serum Creatinine > 3 x Upper Normal Limit (UNL)
Total Bilirubin > 2 x UNL
Alanine-Aminotransferase (ALAT) > 2 x UNL
Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
Prior administration of any biological compound in the last 3 months
Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)
General exclusion criteria
Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
Participation in any interventional clinical trial within the last three months
Known intravenous drug abuse
Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
Facility Information:
Facility Name
ATTIKON University Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34252397
Citation
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.
Results Reference
derived
Learn more about this trial
Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
We'll reach out to this number within 24 hrs