Apremilast in Combination With Clobetasol Spray for the Treatment of Plaque Psoriasis

NCT03453190 | Unknown Phase 4 FDA Drug

• 1 other identifier: WIRB1180837
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area Severity Index (PASI)

  PASI is a measure of psoriatic disease severity

  16 weeks

Study Arms (1)

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.

Combination Product: Apremilast and Clobetasol

Interventions

Apremilast and Clobetasol COMBINATION_PRODUCT

Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.

Psoriasis Patients on Comb. Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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%

Sponsors & Collaborators

• Washington Dermatology Center: lead

Study Sites (1)

Washington Dermatology Center

Rockville, Maryland, 20852, United States

RECRUITING

Related Publications (6)

• Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007 Nov;80(5 Suppl):12-9.

  PMID: 18154219 BACKGROUND

• Papp 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.

  PMID: 22748702 BACKGROUND

• Beutner 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.

  PMID: 16673804 BACKGROUND

• Carey 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.

  PMID: 16488339 BACKGROUND

• Gordon 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.

  PMID: 15655149 BACKGROUND

• Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

  PMID: 357213 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ronald Prussick, MD

CONTACT

3019843000; drprussick@aol.com

Vicki Smith

CONTACT

3019843000; wdcderm22@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: February 25, 2018
• Primary Completion: March 1, 2020
• Study Completion: June 30, 2020
• Last Updated: March 5, 2018

Record last verified: 2018-02

Locations

US (1)