Hidradenitis SuppurativaPhase 2OSIRISNCT04982432
Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa
A Phase 2 study testing Orismilast in people with Hidradenitis Suppurativa, run by Gregor Jemec.
Trial summary
The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Orismilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult patients, 18 years of age or older.
- Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
- Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
- Has a total inflammatory lesions (AN) count of greater than or equal to 2.
- Total draining fistula count of less than or equal to 30.
- A stable analgesic dose for 2 weeks prior to baseline.
Who cannot join
- Presence of active skin lesions other than HS that could interfere with the assessment of HS.
- Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
- Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
- Any oral antibiotic within 28 days prior to baseline visit.
- Receipt of a live vaccine within 14 days prior to screening.
- Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
- Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Orismilast
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrismilastDrug
Also called UNI5001
Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties
| Study group | Role | What they receive |
|---|---|---|
| Orismilast | Experimental | Orismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment. Receives: Drug: Orismilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Baseline in AN (abscesses and nodules) count at Week 16
Total count of abscess and inflammatory nodules
Measured: Day 1 to Week 16
Secondary outcomes (4)
Change from Baseline in abscess, nodule, and draining fistula counts at Week 16
Total count of abscess, inflammatory nodules, and draining fistula
Measured: Day 1 to Week 16
Change from Baseline in IHS4 value at Week 16
ISH4 is a validated international clinimetric scale. The score is based on a count of inflamed lesions. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).
Measured: Day 1 to Week 16
Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16
Completion of questionnaire covering skin pain Patient's Global Assessment of Skin Pain (0=no pain, 10=worst imaginable pain) 0-10 Numerical Rating Scale (NRS).
Measured: Day 1 to Week 16
Change from Baseline in HiSQOL Total Score at Week 16
Patient completion of the Hidradenitis Suppurativa Quality of Life (HiSQOL) questionnaire that contains Hidradenitis Suppurativa specific items such as drainage and odor in addition to more general skin specific items
Measured: Change from Baseline in HiSQOL Total Score at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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
- Model description
- Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gregor Jemec
- Sponsor type
- University, hospital or other
- Collaborators
- UNION therapeutics
- Responsible party
- Sponsor-investigator, Gregor Jemec, Zealand University Hospital
- Investigators
- Gregor Jemec, Professor, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982432
- Sponsor's protocol ID
- OSIRIS [UNI50007-201]
- Other IDs
- 2021-000049-42
- Acronym
- OSIRIS
- Status last verified
- Sep 2021
- First submitted
- 26 Jul 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
- ClinicalTrials.gov ID
- NCT04982432
- Acronym / sponsor ID
- OSIRIS / OSIRIS [UNI50007-201]
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gregor JemecUniversity, hospital or other
- Collaborators
- UNION therapeutics
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Jul 2021 (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.
The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Orismilast | Experimental | Drug: OrismilastOrismilast tablet, oral administration, multiple titrated doses twice daily, 10 mg up to 40 mg, morning and evening, 16 weeks treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adult patients, 18 years of age or older.
- Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
- Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
- Has a total inflammatory lesions (AN) count of greater than or equal to 2.
- Total draining fistula count of less than or equal to 30.
Key exclusion criteria (7 listed)
- Presence of active skin lesions other than HS that could interfere with the assessment of HS.
- Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
- Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
- Any oral antibiotic within 28 days prior to baseline visit.
- Receipt of a live vaccine within 14 days prior to screening.
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 |
|---|---|---|
| OrismilastAlso: UNI5001Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties | Drug | Orismilast |
Primary outcome
Percent change from Baseline in AN (abscesses and nodules) count at Week 16
Time frame: Day 1 to Week 16
Total count of abscess and inflammatory nodules
4 secondary outcomes
Change from Baseline in abscess, nodule, and draining fistula counts at Week 16
Time frame: Day 1 to Week 16
Change from Baseline in IHS4 value at Week 16
Time frame: Day 1 to Week 16
Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16
Time frame: Day 1 to Week 16
Change from Baseline in HiSQOL Total Score at Week 16
Time frame: Change from Baseline in HiSQOL Total Score at Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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.
Gregor Jemec, Professor principal investigator
Zealand University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orismilast in people with Hidradenitis Suppurativa, run by Gregor Jemec.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregor Jemec, Professor (+4547322601, gbj@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from Baseline in AN (abscesses and nodules) count at Week 16 (time frame: Day 1 to Week 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 28 Sep 2021.