NCT01704534

Brief Summary

The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

August 7, 2012

Last Update Submit

April 16, 2024

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativaAcne ectopicaInverse acneUstekinumabStelara

Outcome Measures

Primary Outcomes (1)

  • Change in Sartorius score

    Clinical response is defined as an improvement of the Sartorius score of at least 50%

    76 weeks

Study Arms (1)

Ustekinumab

EXPERIMENTAL

Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28

Drug: Ustekinumab

Interventions

UstekinumabDRUG

subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28

Also known as: Stelara
Ustekinumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Hidradenitis suppurativa Hurley stage II or III
  • No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery
  • The patient has to be able to complete a dutch questionnaire
  • Informed consent must be obtained

You may not qualify if:

  • Not able to complete a Dutch questionnaire
  • Pregnancy or breast feeding
  • Active hepatitis B or C infection, HIV or tuberculosis
  • Treatment with biologics or other immunosuppressive medicine in the previous 3 months
  • Malignancies in the last 10 years with the exception of basal cell carcinoma
  • Demyelinating disorders
  • Heart failure
  • Known allergy to ustekinumab or to its preservatives
  • Live vaccins in the next 3 months Sever liver or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Barbara Horváth, MD-PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

October 11, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

NL(1)