HIDRADENITIS SUPPURATIVA/ACNE INVERSA MedDRA version: 18.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Product Name: MABp1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: XILONIX
Other descriptive name: MABP1
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent provided by the patient • Age above or equal to 18 years • Diagnosis of hidradenitis suppurativa (HS) • Presence of at least three inflamed nodules • HS of Hurley II or III stage disease or rapidly progressive HS of stage I 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • History of systemic lupus erythematosus, of rheumatoid arthritis or of seronegative inflammatory arthritis • Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer) • History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies • Administration of any live (attenuated) vaccine over the last 4 weeks • History of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome • Any present serious bacterial infection namely pneumonia, endocarditis, acute pyelonephritis and intrabdominal infection. These patients can be enrolled once the attending physicians confirm cure by the infection • Hepatic dysfunction defined as any value of transaminases, of ?-glutamyl transpeptidase or of bilirubin greater than twofold the upper normal limit • History of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection • History of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis • Any creatinine value above 1.5 mg/dl • Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks; • Neutropenia defined as lower than 1000 neutrophils/mm3; and • Pregnancy or lactation • History of tuberculosis (latent or active). This will be excluded according to the procedure defined in the screening of patients (see below) • Major surgery within 28 days prior to Day 0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this clinical study is to evaluate the safety and the efficacy of MABp1 compared to placebo in patients with moderate to severe hidradenitis suppurativa. ;Secondary Objective: Not applicable;Primary end point(s): The efficacy of MABp1 in patients with moderate to severe hidradenitis suppurativa (HS) by HiSCR scoring. This will be assessed by the difference of achievement of positive HiSCR (HS clinical response) score between the treatment group and the comparator placebo group at week 12. ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The long-term efficacy of MABp1 in patients with moderate to severe hidradenitis suppurativa by positive HiSCR scoring. This will be assessed by the difference of achievement of HiSCR score between the treatment group and the comparator placebo group at week 24. • The short-and long-term efficacy of MABp1 in patients with moderate to severe HS. This will be assessed by the comparisons of all used scoring systems (HiSCR, PGA, DLQI, disease activity, VAS for disease, VAS for pain and modified Sartorius score) on all study visits. • The effect of MAbp1 on the time to new exacerbation. This will be assessed by comparing the time to new exacerbation from week 0 between the two groups of treatment. ;Timepoint(s) of evaluation of this end point: In all patient visits | — |
Countries
Greece
Contacts
Public ContactKyriaki Kanellakopoulou
Hellenic Institute for the Study of Sepsis
Outcome results
None listed