PsoriasisPhase 4NCT03453190
Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis
A Phase 4 study testing Apremilast and Clobetasol in people with Psoriasis, run by Washington Dermatology Center at 1 site in United States.
Trial summary
Researchers want to find out if giving the drug Apremilast in combination with Clobetasol spray can help people clear their moderate to severe plaque psoriasis quicker than if Apremilast is used by itself. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast and Clobetasol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2018to 30 Jun 2020
- Phase
- Phase 4
- 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
- Must be in general good health (except for disease under study) as judged by the Sponsor Investigator, based on medical history, and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline.
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom not made out of natural [animal] membrane [for example, polyurethane]; plus one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide
- Plaque psoriasis with at least 10% body surface area (BSA) involving the body with or without scalp lesions in adults aged 18 years and older.
Who cannot join
- Other than disease under study, any clinically significant (as determined by the Sponsor Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition 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 baseline, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Malignancy or history of malignancy, except for:
Show all 20Show fewer
- 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.
- Use of any investigational drug within 4 weeks prior to baseline, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Prior treatment with apremilast.
- Concomitant use of drugs that treat psoriasis including but not limited to methotrexate, acitretin, cyclosporine within 4 weeks of baseline.
- Adalimumab, etanercept, efalizumab, infliximab, or certolizumab pegol within 12 weeks prior to baseline.
- Alefacept, briakinumab, ixekizumab, brodalumab or ustekinumab within 24 weeks prior to baseline.
- Use of phototherapy within 4 weeks prior to baseline
- Plaque-type psoriasis with BSA<10%
- Psoriasis predominantly involving the face or folds (groin or axilla)
- Psoriasis only of the palms/soles, pustular or other forms of psoriasis
- Concurrent skin or systemic infection
- History of intolerance to topical steroids or apremilast.
- Topical therapy within 2 weeks of baseline (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Exceptions: Clobetasol Spray 0.05%.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington Dermatology Center
Rockville, Maryland, 20852
Vicki Smith, 301-984-3000, wdcderm22@gmail.com
Ronald Prussick, M.D., 3019843000, drprussick@aol.com
About this study
Researchers want to find out if giving the drug Apremilast in combination with Clobetasol spray can help people clear their moderate to severe plaque psoriasis quicker than if Apremilast is used by itself.
Read the detailed description
People over age 18 with moderate to severe plaque psoriasis who choose to be in the study and pass the four week screening period will visit the study center about 8 times over about 16 weeks. All participants will be given Apremilast, a pill that you take in the morning and at night, and which studies have shown may reduce inflammation and improve psoriasis symptoms. All participants will also be given Clobetasol to spray twice daily for two weeks, then once daily for two weeks, then every other day for two weeks. All drugs and study visits are at no cost to participants.
- Conditions
- Psoriasis
- Being tested
- Apremilast and Clobetasol
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast and ClobetasolCombination product
Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Patients on Comb. Treatment | Other | Patients will be given Apremilast 30 mg bid and Clobetasol Spray 0.05 % bid on a tapering schedule over 16 weeks. Receives: Combination Product: Apremilast and Clobetasol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index (PASI)
PASI is a measure of psoriatic disease severity
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start25 Feb 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington Dermatology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Prussick, Washington Dermatology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453190
- Sponsor's protocol ID
- WIRB1180837
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 5 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007 Nov;80(5 Suppl):12-9.
PubMed 18154219Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.
PubMed 22748702Beutner K, Chakrabarty A, Lemke S, Yu K. An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. J Drugs Dermatol. 2006 Apr;5(4):357-60.
PubMed 16673804Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S171-81. doi: 10.1016/j.jaad.2005.10.029.
PubMed 16488339Gordon KB, Feldman SR, Koo JY, Menter A, Rolstad T, Krueger G. Definitions of measures of effect duration for psoriasis treatments. Arch Dermatol. 2005 Jan;141(1):82-4. doi: 10.1001/archderm.141.1.82. No abstract available.
PubMed 15655149Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
PubMed 357213
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03453190
- Acronym / sponsor ID
- WIRB1180837
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington Dermatology CenterUniversity, hospital or other
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Mar 2018 (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.
Researchers want to find out if giving the drug Apremilast in combination with Clobetasol spray can help people clear their moderate to severe plaque psoriasis quicker than if Apremilast is used by itself.
Detailed description
People over age 18 with moderate to severe plaque psoriasis who choose to be in the study and pass the four week screening period will visit the study center about 8 times over about 16 weeks. All participants will be given Apremilast, a pill that you take in the morning and at night, and which studies have shown may reduce inflammation and improve psoriasis symptoms. All participants will also be given Clobetasol to spray twice daily for two weeks, then once daily for two weeks, then every other day for two weeks. All drugs and study visits are at no cost to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Patients on Comb. Treatment | Other | Combination Product: Apremilast and ClobetasolPatients will be given Apremilast 30 mg bid and Clobetasol Spray 0.05 % bid on a tapering schedule over 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be in general good health (except for disease under study) as judged by the Sponsor Investigator, based on medical history, and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline.
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom not made out of natural [animal] membrane [for example, polyurethane]; plus one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide
- Plaque psoriasis with at least 10% body surface area (BSA) involving the body with or without scalp lesions in adults aged 18 years and older.
Key exclusion criteria (20 listed)
- Other than disease under study, any clinically significant (as determined by the Sponsor Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition 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 baseline, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months 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 |
|---|---|---|
| Apremilast and ClobetasolPatients will receive apremilast and clobetasol with tapering dosages over 16 weeks. | Combination product | Psoriasis Patients on Comb. Treatment |
Primary outcome
Psoriasis Area Severity Index (PASI)
Time frame: 16 weeks
PASI is a measure of psoriatic disease severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Background: PubMed 18154219Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007 Nov;80(5 Suppl):12-9.
- Background: PubMed 22748702Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.
- Background: PubMed 16673804Beutner K, Chakrabarty A, Lemke S, Yu K. An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. J Drugs Dermatol. 2006 Apr;5(4):357-60.
- Background: PubMed 16488339Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S171-81. doi: 10.1016/j.jaad.2005.10.029.
- Background: PubMed 15655149Gordon KB, Feldman SR, Koo JY, Menter A, Rolstad T, Krueger G. Definitions of measures of effect duration for psoriasis treatments. Arch Dermatol. 2005 Jan;141(1):82-4. doi: 10.1001/archderm.141.1.82. No abstract available.
- Background: PubMed 357213Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast and Clobetasol in people with Psoriasis, run by Washington Dermatology Center 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 4 inclusion and 20 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 5 Mar 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ronald Prussick, MD (3019843000, drprussick@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area Severity Index (PASI) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453190, which also lists 6 linked publications.
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 Mar 2018.