Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa

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)).

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Biological: IFX-1

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 12462
    • Attikon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients ≥ 18 years old
2. Written informed consent
3. Diagnosis of HS for at least 1 year
4. Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of which is Hurley Stage II or III
5. Total AN (abscesses and nodules) count ≥3
6. Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals
7. Failure of previous antimicrobial treatments

Exclusion Criteria:

1. Body weight above 150 kg or body weight below 60 kg
2. Has a draining fistula count of greater than 30 at baseline
3. Surgical management planned within the next 24 weeks
4. Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days

5. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study

   1. Active infection
   2. Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
   3. Depression
   4. History of systemic lupus erythematosus or rheumatoid arthritis
   5. Any immunodeficiency disease
   6. Active hematological or solid malignant tumor
   7. 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.

6. One of the following abnormal laboratory results

   1. White blood cell count < 2,500/mm3
   2. Neutrophil count < 1000/mm3
   3. Serum Creatinine > 3 x Upper Normal Limit (UNL)
   4. Total Bilirubin > 2 x UNL
   5. Alanine-Aminotransferase (ALAT) > 2 x UNL
   6. Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
7. Prior administration of any biological compound in the last 3 months
8. Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
9. Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)

10. General exclusion criteria

    1. Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    2. 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
    3. Participation in any interventional clinical trial within the last three months
    4. Known intravenous drug abuse
    5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: IFX-1	Biological: IFX-1; chimeric, monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)	up to Day 134
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)	up to Day 134

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of IFX-1	From Day 1 until Day 134
Plasma concentration of C5a	Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Percentage change from baseline in total abscess and nodule (AN) count per time point	Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
Hidradenitis Suppurativa Clinical Response (HiSCR) per time point	Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
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	Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
HS-PGA score per time point	Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
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	At each visit from Day 1 until Day 134
VAS pain score per time point	At each visit from Day 1 until Day 134
Change from baseline in VAS pain score per time point	At each visit from Day 1 until Day 134
VAS disease score per time	At each visit from Day 1 until Day 134
Change from baseline in VAS disease score per time point	At each visit from Day 1 until Day 134
Dermatology Life Quality Index (DLQI) per time point	Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Change from baseline in DLQI per time point	Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134

Collaborators and Investigators

• Sponsor: InflaRx GmbH

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: IFX-1-P2.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO