Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must be over 18 years of age. 2. Diagnosis of Hidradenitis suppurativa (HS) for at least 1 year prior to Baseline. 3. Diagnosis of HS Hurley stage II or III made by a consultant dermatologist. 4. Capable of giving informed consent. 5. Naïve to previous anti-TNF treatment 6. Patients must have an AN (total count of abcesses and inflammatory nodules) count of 3 or greater and a draining fistula count = 20 7. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Women of child bearing potential should use effective birth control methods throughout the trial and for at least 5 months afterwards. 8. Subject must have stable HS for at least 7 days prior to screening visit and at Baseline visit. 9. Subjects have clinically acceptable laboratory and ECG/CXR findings at screening visit. 10. Patients should have an adequate indication for receiving Humira treatment fro hidradenitis suppurativa as per current SmPC. 11. Clinically acceptable laboratory findings imply that blood results are within the expected normal reference range for the laboratories in both St Vincent’s Hospital and the Mater Hospital. 12. ECGs should show no abnormalities /no new changes compared with previous ECGs 13. CXR findings should be non- significant/ stable compared with previous CXRs. 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Allergy/sensitivity to study medications or their ingredients 2. Previously treated with Humira or another anti-TNF therapy 3. Pregnancy/breast feeding 4. <18 years of age 5. Major Psychiatric illness 6. Contraindication to anti-TNF treatment 7. History of moderate to severe congestive heart failure (New York Health Association [NYHA] class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator would put the subject at risk by participation in the protocol; 8. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease; 9. History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV); 10. Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study 11. Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBcAb/HBsAb positive subjects 12. Chronic recurring infections or active TB; 13. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. 14. Subjects who have participated in another study and received any other investigational agent within 1 month 15. Subjects unable to provide written informed consent 16. Subjects who have any other significant disease or disorder (including uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accident) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. 17. Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements. 18. Prior or concurrent malignancy 19. AST or ALT = 3 x ULN 20. Creatinine clearance (CrCl) < 60 mL/min measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula 21. Subjects have clinically significant ECG findings as judged by the investigator 22. Scheduled for procedures requiring general anaesthesia during the study 23. Latex allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TTo stratify patients with moderate to severe HS into those who respond to treatment (responders) with Humira and those who fail to respond to treatment with Humira (non-responders). The cytokine and chemokine profiles in lesional and perilesional microdialysate will be compared between responders and non-responders.;Secondary Objective: To discover novel biomarkers that can be used to predict response to Humira treatment.;Primary end point(s): Inflammatory profiles of responders vs non responders in lesional and peri-lesional skin biopsies. Inflammatory mediator profiles of responders vs non responders in lesional and perilesional microdialysate.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients achieving clinical response after 12 weeks treatment with Humira, using HiSCR (Time line: Baseline to week 12). This will stratify patients into non responders and responders for secondary analysis 2. Change from baseline in AN count 3. Change from baseline in Dermatologic Life Quality Index (DLQI) 4. Change from baseline in pain VAS 5. Novel biomarkers that can be used to predict response to Humira treatment. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Ireland
Contacts
Public ContactRabia Hussain
University College Dublin
Outcome results
None listed