A Proof of Concept Study to Evaluate the Effectiveness of... | NCT01704534

Studies
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa

NCT01704534

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Apr 18, 2024Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Hidradenitis Suppurativa

Interventions

Ustekinumab

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-002091-16	EudraCT Number

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Aug 7, 2012

First Submission Date that Met QC Criteria

Oct 9, 2012

First Posted Date

Oct 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Name	Class
Janssen-Cilag B.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ustekinumab	Experimental	Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28	Drug: Ustekinumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ustekinumab	Drug	subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28	Ustekinumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Sartorius score	Clinical response is defined as an improvement of the Sartorius score of at least 50%	76 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Horváth, MD-PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Groningen		Groningen		9700RB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069549	Ustekinumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided