Hidradenitis SuppurativaPhase 2SMASHNCT03049267
Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis
A Phase 2 study testing Apremilast in people with Hidradenitis Suppurativa, run by M.B.A. van Doorn at 1 site in Netherlands.
Trial summary
Study design: A double-blind randomised placebo-controlled trial Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks. 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?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Feb 2017to 28 Jun 2018
- 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
- Adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);
- HS of more than 6 months duration; have lesions in at least two anatomical locations.
Who cannot join
- Contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS;
- Presence of other uncontrolled major disease;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial
Study design: A double-blind randomised placebo-controlled trial
Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.
Read more
Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):
- of patients receiving apremilast compared to placebo;
- within both groups relative to baseline (t=0).
Secondary objectives:
- To prospectively evaluate the clinical efficacy of apremilast.
- To assess the effect of apremilast on patient reported outcomes measures.
- To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.
Read the detailed description
Rationale:
Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.
Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Apremilast, Placebo Oral Tablet
- Keywords
- acne inversa
- 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
Also called Otezla, CC-10004
Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
Placebo Oral TabletDrug
Also called Placebo comparator
Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | N=15 Receives: Drug: Apremilast |
| Placebo Oral Tablet | Placebo comparator | N=5 Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.
measurement by qPCR
Measured: t=16 weeks
Change of expression levels of inflammatory cytokine protein in HS lesional skin.
measurement by ELISA
Measured: t=16 weeks
Secondary outcomes (8)
Abscesses count
Total number of abscesses [A]
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Nodule count
Total number of inflammatory [N] and non-inflammatory nodules
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Fistula count
Total count of draining fistulas
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score
Based on the HS lesion count
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Hidradenitis Suppurativa Clinical Response (HiSCR)
Based on the AN count; The proposed definition of 50% and 30% responders to treatment (HiSCR achievers) is respectively: (i) at least a 50% and 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline.
Measured: t=0 weeks, t=16 weeks
Numerical Rating Scale (NRS)
To assess the patient reported outcome measures (PROMs) pain, pruritus and patient disease global assessment score;
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Dermatology Life Quality Index (DLQI)
To assess the patient reported outcome measures (PROM) quality of life
Measured: t=0 weeks, t=4 weeks, t=16 weeks
Incidence of Treatment-Emergent Adverse Events
Vital signs: heart rate, temperature, blood pressure. Patient reported adverse events Safety laboratories: White blood cell count, Absolute neutrophil count, Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase
Measured: Multiple time points between t=0 weeks and t=16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start2 Feb 2017
- Primary completion6 Dec 2017
- Study completion28 Jun 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.B.A. van Doorn
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, M.B.A. van Doorn, Erasmus Medical Center
- Investigators
- Errol Prens, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049267
- Sponsor's protocol ID
- SMASH trial
- Acronym
- SMASH
- Status last verified
- Jul 2018
- First submitted
- 25 Oct 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03049267
- Acronym / sponsor ID
- SMASH / SMASH trial
- Conditions
- Hidradenitis Suppurativa
- Keywords
- acne inversa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.B.A. van DoornUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 10 Feb 2017 (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.
Study design: A double-blind randomised placebo-controlled trial
Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.
Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):
- of patients receiving apremilast compared to placebo;
- within both groups relative to baseline (t=0).
Secondary objectives:
- To prospectively evaluate the clinical efficacy of apremilast.
- To assess the effect of apremilast on patient reported outcomes measures.
- To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.
Detailed description
Rationale:
Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.
Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastN=15 |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletN=5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);
- HS of more than 6 months duration; have lesions in at least two anatomical locations.
Key exclusion criteria (3 listed)
- Contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS;
- 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 |
|---|---|---|
| ApremilastAlso: Otezla, CC-10004Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks. | Drug | Apremilast |
| Placebo Oral TabletAlso: Placebo comparatorFive patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks. | Drug | Placebo Oral Tablet |
Primary outcome
Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.
Time frame: t=16 weeks
measurement by qPCR
Change of expression levels of inflammatory cytokine protein in HS lesional skin.
Time frame: t=16 weeks
measurement by ELISA
8 secondary outcomes
Abscesses count
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Nodule count
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Fistula count
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: t=0 weeks, t=16 weeks
Numerical Rating Scale (NRS)
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Dermatology Life Quality Index (DLQI)
Time frame: t=0 weeks, t=4 weeks, t=16 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: Multiple time points between t=0 weeks and t=16 weeks
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 24 Jul 2018.
- 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
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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
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe 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.
Errol Prens principal investigator
Erasmus Medical Center
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 M.B.A. van Doorn 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 2 inclusion and 3 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 24 Jul 2018. 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. Some participants in this study may receive a placebo. 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 of expression levels of inflammatory cytokine mRNA in HS lesional skin. (time frame: t=16 weeks). The study lists 2 primary outcomes in all. 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 24 Jul 2018.