Hidradenitis SuppurativaPhase 2HSNCT02695212
Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa
A Phase 2 study testing Apremilast in people with Hidradenitis Suppurativa, run by Florida Academic Dermatology Centers at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS). 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?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2017
- 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
None listed.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
- Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study drug dose (this includes father's who plan on fathering a child within 6 months after their last study drug dose.
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- Active substance abuse or a history of substance abuse within 6 months prior to Screening
- Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening. .
- Patient with diagnosis or suspected Crohns disease
- Patient who is on a stable dose of analgesics, will be allowed to remain on them. No new opiates will be permitted during the trial.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmocokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Prior treatment with Apremilast
- Known allergy to Apremilast
- Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months
- Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly
- Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access
- Patient with significant scarring, fistulas, or sinus tract involvement will be excluded. Only subjects with inflammatory abscesses and nodules will be allowed to enter the study.
- Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to Baseline
- Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
- History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV);
- Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study;
- Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBsAb positive subjects; Or Hepatitis C
- Chronic recurring infections or active TB;
- Evidence of dysplasia
- Pregnant (or considering becoming pregnant) or lactating females.
- The use of any prior biologic therapy is prohibited
- Subjects currently undergoing any of the following treatments for HS will require a 2 week wash-out period: Minocycline; Tetracycline; Clindamycin; Rifampicin and Steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Academic Dermatology Centers
Coral Gables, Florida, 33134
About this study
Official title: A Phase 2 Open-label Single Center Study to Evaluate the Efficacy of Apremilast for the Treatment of Moderate Hidradenitis Suppurativa
The primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS).
Read the detailed description
This study is an open-label 28-week trial. All Subjects will receive Apremilast with the initial titrating dose as per package insert (10mg per day on day #1, escalating to 30mg twice daily at day #6 and continuation at this dose).
The primary efficacy endpoint is:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint..
The Secondary endpoints are:
- The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score at week 16
- Changes in Modified Sartorius scale from Baseline to Week 16
- The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score at week 16
- Dermatology Life Quality Index or DLQI,
The study will be conducted over 24 weeks on active therapy followed by a four week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, and then a observational follow up 4 weeks afterwards. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Apremilast
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Investigational Product: Apremilast
Doses: Period A:
10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6
Period B:
30mg Twice per day, day #7 through week #24
Period C:
Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Apremilast ( open label) | Experimental | Investigational Product: Apremilast
Doses: Period A:
10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6
Period B:
30mg Twice per day, day #7 through week #24
Period C:
Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint..
Measured: Week 16
Secondary outcomes (3)
The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score
The number of patients achieving a one point reduction in thePhysician's Global Assessment (PGA) score
Measured: Week 16
Changes in Modified Sartorius scale from Baseline
Changes in Modified Sartorius scale from Baseline
Measured: From Baseline to Week 16
3. The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score
- The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Academic Dermatology Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695212
- Sponsor's protocol ID
- AP-CL-HYDSUP-PI-004953
- Acronym
- HS
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Single Center Study to Evaluate the Efficacy of Apremilast for the Treatment of Moderate Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT02695212
- Acronym / sponsor ID
- HS / AP-CL-HYDSUP-PI-004953
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida Academic Dermatology CentersUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Mar 2016 (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 primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS).
Detailed description
This study is an open-label 28-week trial. All Subjects will receive Apremilast with the initial titrating dose as per package insert (10mg per day on day #1, escalating to 30mg twice daily at day #6 and continuation at this dose).
The primary efficacy endpoint is:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint..
The Secondary endpoints are:
- The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score at week 16
- Changes in Modified Sartorius scale from Baseline to Week 16
- The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score at week 16
- Dermatology Life Quality Index or DLQI,
The study will be conducted over 24 weeks on active therapy followed by a four week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, and then a observational follow up 4 weeks afterwards. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast ( open label) | Experimental | Drug: ApremilastInvestigational Product: Apremilast Doses: Period A: 10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6 Period B: 30mg Twice per day, day #7 through week #24 Period C: Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (31 listed)
- The presence of any of the following will exclude a subject from enrollment:
- Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
- Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
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 |
|---|---|---|
| ApremilastInvestigational Product: Apremilast Doses: Period A: 10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6 Period B: 30mg Twice per day, day #7 through week #24 Period C: Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral | Drug | Apremilast ( open label) |
Primary outcome
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: Week 16
defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint..
3 secondary outcomes
The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score
Time frame: Week 16
Changes in Modified Sartorius scale from Baseline
Time frame: From Baseline to Week 16
3. The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score
Time frame: Week 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 2 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Apremilast in people with Hidradenitis Suppurativa, run by Florida Academic Dermatology Centers at 1 site in United States.
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 0 inclusion and 31 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 2 Apr 2019. 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 United States. 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?
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: 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 2 Apr 2019.