Hidradenitis suppurativa MedDRA version: 19.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Product Name: IFX-1
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: n/a
Current Sponsor code: IFX-1 (former code: CaCP29)
Other descriptive name: chimeric monoclonal antibody, IgG4 sub
Sponsors
InflaRx GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years old 2. Written informed consent 3. Diagnosis of HS for at least 1 year 4. HS lesions in at least 2 distinct anatomic areas, one of which isHurley 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 NOTE: a primary failure is defined as an at least 12 week treatment with a biological compound without effect and a secondary failure as achieving an initial response after at least 12 week treatment with a biological compound followed by a relapse. 7. Failure of previous antimicrobial treatments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Body weight above 150kg 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 a) Active infection b) Severe congestive heart failure (i.e., NYHA Class IV) c) Depression d) History of systemic lupus erythematosus or rheumatoid arthritis e) Any immunodeficiency disease f) Active hematological or solid malignant tumor g) 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 a) White blood cell count 3 x Upper Normal Limit (UNL) d) Total bilirubin > 2 x UNL e) Alanine-Aminotransferase (ALAT) > 2x UNL f) 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 the past 30 days (e.g., cyclosporine, tacrolimus) 10.General exclusion criteria a)Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women b)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 c)Participation in any interventional clinical trial within the last three months d)Known intravenous drug abuse e)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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the safety of IFX-1 administered over 8 weeks in patients with moderate to severe hidradenitis suppurativa;Secondary Objective: To assess the pharmacokinetics and pharmacodynamics of IFX-1 in patients with hidradenitis suppurativa as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., HiSCR, DLQI, VAS for disease, VAS for pain, HS-PGA, modified Sartorius Score) for further hypotheses;Primary end point(s): •Treatment emergent adverse events (TEAE) from Day 1 until Day 50 and Day 134, • Relationship of TEAEs • Serious TEAEs, and relationship of serious TEAEs • Number of patients with detection of anti-drug antibodies (pre-/post-dosing). ;Timepoint(s) of evaluation of this end point: Number of TEAEs from Day 1 until Day 50 and Day 134, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective of this clinical trial is the assessment of pharmacokinetics (PK) and pharmacodynamics (PD) of IFX-1 in patients with moderate to severe HS. •The PK is measured by plasma concentration of IFX-1 which is determined several times after administration of IFX-1 Analysis of plasma concentration of IFX-1 will comprise the following measures: • Plasma concentration at each timepoint, Parameters will be assessed for each of the nine infusions. PD is primarily measured by plasma concentration of free, detectable C5a which is determined several times after administration of IFX-1. Plasma concentration of free, detectable C5a will be described by: • Plasma concentration of free C5a at each time point • Relative and absolute change of plasma concentration of free detectable C5a at each time point compared to baseline (i.e., Day 1) A secondary object of the trial is to describe efficacy of IFX-1. Key efficacy endpoints are: • Clinical Hidradenitis suppurativa parameters - Absolute and percentage change from baseline (i.e., Day 1) in AN count per time point • HiSCR -HiSCR response per time point •HS-PGA - Achievement of HS-PGA of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline (i.e., Day 1) at Day 22, 50, 134 - HS-PGA score per time point • VAS pain - Achievement of at least a 30% reduction and at least a 10 mm reduction in skin pain (VAS), among patients who had a baseline pain assessment = 30 mm (i.e., assessment at Day 1) - VAS pain score per time point and change compared to the VAS pain score at baseline (i.e., Day 1) •VAS disease - VAS disease score per time point and change compared to the VAS disease score at baseline (i.e., Day 1). • DLQI - DLQI per time point and change compared to baseline DLQI (i.e., Day 1) over time ;Timepoint(s) of evaluation of this end point: PK , PD - at various timepoints Efficacy - various timepoints from basel | — |
Countries
Greece
Contacts
Public ContactInflaRx GmbH
InflaRx GmbH
Outcome results
None listed