Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2016-002988-33-GR
EUCTR2016-002988-33-GRActive, not recruitingPhase 1

An open label Phase II trial to evaluate the safety of IFX-1 in patients with moderate to severe Hidradenitis suppurativa

InflaRx GmbH0 sitesStarted: October 14, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

  • •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
  • •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

Investigators

Similar Trials

Active, not recruiting
Not Applicable
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - Pediatric trial with Intelence as an Active NNRTI Option (PIANO)HIV-1 infectionMedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1
EUCTR2007-007086-21-BETibotec Pharmaceuticals100
Active, not recruiting
Not Applicable
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents - NDHIV-1 INFECTIONMedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1
EUCTR2007-007086-21-ITTIBOTEC PHARMACEUTICALS LTD.100
Active, not recruiting
Phase 1
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - Pediatric trial with Intelence as an Active NNRTI Option (PIANO)
EUCTR2007-007086-21-GBTibotec Pharmaceuticals101
Active, not recruiting
Not Applicable
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - Pediatric trial with Intelence as an Active NNRTI Option (PIANO)
EUCTR2007-007086-21-PTTibotec Pharmaceuticals100
Active, not recruiting
Not Applicable
A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - Pediatric trial with Intelence as an Active NNRTI Option (PIANO)
EUCTR2007-007086-21-NLTibotec Pharmaceuticals Limited100