Hidradenitis SuppurativaPhase 2HiTSNCT01704534
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa
A Phase 2 study testing Ustekinumab in people with Hidradenitis Suppurativa, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Heart failure
- Known allergy to ustekinumab or to its preservatives
- Live vaccins in the next 3 months Sever liver or renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Ustekinumab
- Keywords
- Hidradenitis suppurativa, Acne ectopica, Inverse acne, Ustekinumab, Stelara
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called Stelara
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab | Experimental | Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28 Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sartorius score
Clinical response is defined as an improvement of the Sartorius score of at least 50%
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Responsible party
- Sponsor
- Investigators
- Barbara Horváth, MD-PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704534
- Sponsor's protocol ID
- 662507
- Other IDs
- 2011-002091-16
- Acronym
- HiTS
- Status last verified
- Apr 2024
- First submitted
- 7 Aug 2012
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)
- ClinicalTrials.gov ID
- NCT01704534
- Acronym / sponsor ID
- HiTS / 662507
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, Acne ectopica, Inverse acne, Ustekinumab, Stelara
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab | Experimental | Drug: UstekinumabUstekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: Stelarasubcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28 | Drug | Ustekinumab |
Primary outcome
Change in Sartorius score
Time frame: 76 weeks
Clinical response is defined as an improvement of the Sartorius score of at least 50%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Horváth, MD-PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ustekinumab in people with Hidradenitis Suppurativa, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sartorius score (time frame: 76 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.