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

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Combination product: Apremilast and Clobetasol

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ronald Prussick, MD; Phone Number: 3019843000; Email: drprussick@aol.com
• Study Contact Backup: Name: Vicki Smith; Phone Number: 3019843000; Email: wdcderm22@gmail.com

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Recruiting
      • Washington Dermatology Center
      • Contact: Vicki Smith; Phone Number: 301-984-3000; Email: wdcderm22@gmail.com
      • Contact: Ronald Prussick, M.D.; Phone Number: 3019843000; Email: drprussick@aol.com
      • Principal Investigator: Ronald Prussick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).

2. 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

3. 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.

Exclusion Criteria:

1. 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.
2. Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
3. 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.
4. Pregnant or breast feeding.
5. Active substance abuse or a history of substance abuse within 6 months prior to Screening.

6. Malignancy or history of malignancy, except for:

   1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
   2. treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
7. Use of any investigational drug within 4 weeks prior to baseline, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
8. Prior treatment with apremilast.
9. Concomitant use of drugs that treat psoriasis including but not limited to methotrexate, acitretin, cyclosporine within 4 weeks of baseline.
10. Adalimumab, etanercept, efalizumab, infliximab, or certolizumab pegol within 12 weeks prior to baseline.
11. Alefacept, briakinumab, ixekizumab, brodalumab or ustekinumab within 24 weeks prior to baseline.
12. Use of phototherapy within 4 weeks prior to baseline
13. Plaque-type psoriasis with BSA<10%
14. Psoriasis predominantly involving the face or folds (groin or axilla)
15. Psoriasis only of the palms/soles, pustular or other forms of psoriasis
16. Concurrent skin or systemic infection
17. History of intolerance to topical steroids or apremilast.
18. 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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Psoriasis Patients on Comb. Treatment; 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; Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area Severity Index (PASI)	PASI is a measure of psoriatic disease severity	16 weeks

Collaborators and Investigators

• Sponsor: Washington Dermatology Center

Publications and helpful links

General Publications

• 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.
• 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.
• Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
• Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007 Nov;80(5 Suppl):12-9.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Clobetasol; Apremilast
• Other Study ID Numbers: WIRB1180837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes