Hidradenitis SuppurativaPhase 2HiGUSNCT04061395
Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
A Phase 2 study testing Guselkumab in people with Hidradenitis Suppurativa, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin. 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?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2019to 1 Apr 2022
- 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
- moderate to severe HS
- treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
- HS diagnosis of at least 1 year;
- minimum of two anatomical locations with HS lesions
- minimum of 4 active abscesses and/or inflammatory nodules (AN).
Who cannot join
- contra-indication for guselkumab;
- previous use of guselkumab;
- use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
- presence of other uncontrolled major disease;
- pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen, 9713 GZ
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland
About this study
Official title: Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.
The total duration of the treatment period per subject is 16 weeks.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Guselkumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabBiological
Also called Tremfya
See study arm description.
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab | Experimental | Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks. Receives: Biological: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.
Measured: Week 0 and 16
Secondary outcomes (7)
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.
Measured: Week 0, 4, 12, 16.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
The IHS4 score will be calculated by multiplying the number of nodules by 1, the number of abscesses by 2 and the number of draining fistulas by 4 and adding up these three outcomes into a total score.
Measured: Week 0, 4, 12, 16.
Patient reported outcomes - Patient Global Assessment
Patient will be asked to assess his or her skin disease activity with in 5 categories.
Measured: Every four weeks
Patient reported outcomes - Itch Numeric Rating Scale
Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).
Measured: Week 0, 4, 8, 12 and 16
Patient reported outcomes - Pain Numeric Rating Scale
Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).
Measured: Week 0, 4, 8, 12 and 16
Patient reported outcomes - Patient treatment satisfaction score
Patient will be asked to score his or her satisfaction about the treatment at baseline and at week 16 on a numeric rating scale from 0 (completely unsatisfied) to 10 (completely satisfied).
Measured: Week 0 and 16
Patient reported outcomes - Dermatology Life Quality Index
A survey containing 10 questions regarding multiple aspects of the quality of life. Each question has 4 answer possibilities: 'not at all', 'a little', 'a lot' and 'very much'. These answers correspond with 0,1,2 or 3 points respectively. The total score can range from 0 to 30 points.
Measured: Week 0, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Dec 2021
- Study completion1 Apr 2022
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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Other
- 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 Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061395
- Sponsor's protocol ID
- CNTO1959HDS2002
- Acronym
- HiGUS
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
- ClinicalTrials.gov ID
- NCT04061395
- Acronym / sponsor ID
- HiGUS / CNTO1959HDS2002
- Conditions
- Hidradenitis Suppurativa
- 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 Ltd.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 19 Aug 2019 (actual)
- 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.
This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.
The total duration of the treatment period per subject is 16 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guselkumab | Experimental | Biological: GuselkumabGuselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- moderate to severe HS
- treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
- HS diagnosis of at least 1 year;
- minimum of two anatomical locations with HS lesions
- minimum of 4 active abscesses and/or inflammatory nodules (AN).
Key exclusion criteria (5 listed)
- contra-indication for guselkumab;
- previous use of guselkumab;
- use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
- presence of other uncontrolled major disease;
- pregnant or lactating women
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 |
|---|---|---|
| GuselkumabAlso: TremfyaSee study arm description. | Biological | Guselkumab |
Primary outcome
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
Time frame: Week 0 and 16
Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.
7 secondary outcomes
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: Week 0, 4, 12, 16.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
Time frame: Week 0, 4, 12, 16.
Patient reported outcomes - Patient Global Assessment
Time frame: Every four weeks
Patient reported outcomes - Itch Numeric Rating Scale
Time frame: Week 0, 4, 8, 12 and 16
Patient reported outcomes - Pain Numeric Rating Scale
Time frame: Week 0, 4, 8, 12 and 16
Patient reported outcomes - Patient treatment satisfaction score
Time frame: Week 0 and 16
Patient reported outcomes - Dermatology Life Quality Index
Time frame: Week 0, 4, 8, 12 and 16
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 5 Apr 2024.
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Guselkumab in people with Hidradenitis Suppurativa, run by University Medical Center Groningen at 2 sites 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 5 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 5 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 2 sites 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?
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab. (time frame: Week 0 and 16). 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 5 Apr 2024.