Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON37989
NL-OMON37989
Completed
Phase 2

A prospective *proof of concept study* to evaluate the potential efficacy of ustekinumab in patients with moderate to severe hidradenitis suppurativa (acne ectopica) - HiTS (Hidradenitis suppurativa Treatment with Stelara)

niversitair Medisch Centrum Groningen0 sites20 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionshidradenitis suppurativaacne ectopicaacne inversa10040798

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
hidradenitis suppurativa
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
20
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patient above 18 to 65 years old
  • •Patient with hidradenitis suppurativa Hurley stage II\-III
  • •Failure on conventional therapy with topical and oral antibiotics or immunosuppresiva or surgical intervention or on previous TNF alpha therapy (is not obligatory)
  • •Patient has to be able to fill in a dutch formulated questionnaire
  • •Signed informed consent
  • •Women of childbaring age should use contraception

Exclusion Criteria

  • •Patients unable to fill in the questionnaires (mentally or physically)
  • •Pregnancy or breast feeding patients
  • •Patients with an active (chronic) infection, e.g. hepatitis B or C, HIV, tuberculosis
  • •History of malignancy in past 10 years, except a basal cell carcinoma
  • •Patients with demyelinating disease
  • •Heartfailure NYHA class III\-IV
  • •Patients with a known allergy/hypersensitivity reaction to ustekinumab or one of the preservatives
  • •Vaccination with living virus/bacterium \< 3 months before starting ustekinumab
  • •Severe liver or kidney dysfunction \> 1\.5 times of the maximum allowable value

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
Open pilot trial of a prototype emotional wellbeing app for adolescentsAnxietyDepression
ACTRN12618000273280niversity of Auckland40
Not yet recruiting
Phase 1
Extended intensive care in cases of brain death due to traumatic brain injury having diffuse axonal injuryHealth Condition 1: - Health Condition 2: S062- Diffuse traumatic brain injuryHealth Condition 3: S062- Diffuse traumatic brain injuryHealth Condition 4: S062- Diffuse traumatic brain injury
CTRI/2021/06/033958Himanshu Bansal Foundation
Completed
Not Applicable
A proof of concept study to evaluate the impact of a food supplement on uptake and anti-inflammatory properties of omega-3 fatty acid derived specialized pro-resolution lipid mediatorsHealthy volunteers
DRKS00023304Evonik Operations GmbH19
Completed
Not Applicable
A proof of concept study to evaluate the impact of a food supplement on production of short chain fatty acids and microbiome in healthy subjectshealthy volunteers
DRKS00023166Evonik Operations GmbH18
Active, not recruiting
Phase 3
The effect of dupilumab on airway twitchiness in severe asthmaAdult patients with severe asthma with type 2 inflammationRespiratory
ISRCTN70810039niversity of Dundee20