A trial to evaluate the safety of study drug, IFX-1, in patients with moderate to severe hidradenitis suppurativa.
- Conditions
- Hidradenitis suppurativaMedDRA version: 19.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-002988-33-GR
- Lead Sponsor
- InflaRx GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 < 2,500/mm3
b) Neutrophil count < 1000/mm3
c) Serum creatinine > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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, <br>• Relationship of TEAEs<br>• Serious TEAEs, and relationship of serious TEAEs<br>• Number of patients with detection of anti-drug antibodies (pre-/post-dosing).<br>;Timepoint(s) of evaluation of this end point: Number of TEAEs from Day 1 until Day 50 and Day 134, <br>
- Secondary Outcome Measures
Name Time Method