Apremilast and Moderate to Severe Chronic Hand Dermatitis

NCT03741933 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: AP-CL-DERMAT-PI-13069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators have designed a pilot study involving chronic hand dermatitis (CHD) patients who attend the dermatology clinic at the George Washington Medical Faculty Associates (GW MFA) in order to assess the efficacy and safety of apremilast treatment for the treatment of moderate to severe CHD.

Conditions

Chronic Hand Dermatitis

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Apremilast 30mg twice daily administered as monotherapy in the treatment of moderate-to-severe CHD as assessed by improvement of the Physician Global Assessment (PGA).

  PGA classifies the severity of CHD into five categories (clear, almost clear, mild, moderate, and severe). The PGA scale ranges from 0 (no symptoms) to 4 (severe disease). PGA ratings will be based on an integrated clinical picture of signs, symptoms, and the extent of disease.

  24 weeks

Secondary Outcomes (4)

• To evaluate the safety and tolerability of Apremilast 30mg twice daily through incidence of adverse events.

  24 weeks

• To evaluate CHD lesion time to response (TTR) as assessed by Modified Total Lesion Symptom Score (mTLSS).

  24 weeks

• To evaluate the patient's perception of CHD severity improvement as assessed by the Patient Global Assessment (PaGA).

  24 weeks

• To evaluate the patient's health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire a measurement of the patient's subjective symptoms.

  24 weeks

Study Arms (1)

Apremilast

EXPERIMENTAL

30 mg twice daily to be administered for a period of 6 months

Drug: Apremilast 30mg

Interventions

Apremilast 30mg DRUG

Apremilast 30 mg tablet

Also known as: Otezla, CC-10004

Apremilast

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 18-79 years.
• Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Clinical diagnosis of CHD as defined by hand dermatitis for more than 6 months or more than 2 flares within 12 months.
• Moderate to severe CHD, defined as a PGA score of 3 (moderate) or 4 (severe).
• History of AD, childhood eczema, ACD, or ICD.
• History of disease that is unresponsive to conventional treatment (i.e. corticosteroids, calcineurin inhibitors, phototherapy) for CHD. Lack of response to treatment is defined as an unsatisfactory outcome (no response, transient response to ongoing treatment or lack of tolerability) based on patient history and medical records.
• No other active skin diseases or acute skin infections dominating the clinical picture.
• Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below:
• 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;
• 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.
• † A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
• § The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

You may not qualify if:

• \<18 or \>79 years of age.
• Evidence of tinea mannum involving the hands (verified by positive fungal culture).
• Evidence of an active untreated infection (bacterial, fungal, viral etc) involving the hands at baseline visit.
• Use of topical corticosteroids on the hands within 2 weeks prior to baseline visit.
• Use of topical calcineurin inhibitor (tacrolimus, pimecrolimus) on the hands within 2 weeks prior to baseline visit.
• Use of crisaborole on the hands within 2 weeks prior to baseline visit.
• Use of light based treatments on the hands within 1 month prior to baseline visit.
• Use of systemic therapy (cyclosporine, azathioprine, methotrexate, alitretinoin) within 4 weeks prior to the start of study medication OR 5 pharmacokinetic / pharmacodynamics half-lives (whichever is longer).
• Inability to make study visits or anticipated poor compliance.
• Pregnant females or nursing mothers. Eligible women of reproductive age will be required to adhere to strict pregnancy prevention measures, which includes a negative urine pregnancy test at screening and subsequent visits.
• History of Tuberculosis, Hepatitis B, C, or HIV.
• Any history or evidence of a medical comorbidity that would make the subject, in the opinion of the investigator, unsuitable for the study.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinology, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• Life threatening illness that would interfere with the subject's ability to complete the study.

Sponsors & Collaborators

• George Washington University: lead
• Celgene Corporation: collaborator

Study Sites (1)

George Washington University Department of Dermatology

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (7)

• Coenraads PJ. Hand eczema. N Engl J Med. 2012 Nov 8;367(19):1829-37. doi: 10.1056/NEJMcp1104084.

  PMID: 23134383 BACKGROUND

• Menne T, Johansen JD, Sommerlund M, Veien NK; Danish Contact Dermatitis Group. Hand eczema guidelines based on the Danish guidelines for the diagnosis and treatment of hand eczema. Contact Dermatitis. 2011 Jul;65(1):3-12. doi: 10.1111/j.1600-0536.2011.01915.x.

  PMID: 21658053 BACKGROUND

• English J, Aldridge R, Gawkrodger DJ, Kownacki S, Statham B, White JM, Williams J. Consensus statement on the management of chronic hand eczema. Clin Exp Dermatol. 2009 Oct;34(7):761-9. doi: 10.1111/j.1365-2230.2009.03649.x.

  PMID: 19747339 BACKGROUND

• Berg S. Prävalenz von Handekzemen in Heidelberg und weltweit - die Heidelberger Prävalenzstudie im Vergleich mit Ergebnissen aus der Literatur. Dissertation, Heidelberg, 2005

  BACKGROUND

• Hald M, Berg ND, Elberling J, Johansen JD. Medical consultations in relation to severity of hand eczema in the general population. Br J Dermatol. 2008 Apr;158(4):773-7. doi: 10.1111/j.1365-2133.2007.08431.x. Epub 2008 Jan 30.

  PMID: 18241259 BACKGROUND

• Brunner PM, Leung DYM, Guttman-Yassky E. Immunologic, microbial, and epithelial interactions in atopic dermatitis. Ann Allergy Asthma Immunol. 2018 Jan;120(1):34-41. doi: 10.1016/j.anai.2017.09.055. Epub 2017 Nov 7.

  PMID: 29126710 BACKGROUND

• Bissonnette R, Haydey R, Rosoph LA, Lynde CW, Bukhalo M, Fowler JF, Delorme I, Gagne-Henley A, Gooderham M, Poulin Y, Barber K, Jenkin P, Landells I, Pariser DM. Apremilast for the treatment of moderate-to-severe palmoplantar psoriasis: results from a double-blind, placebo-controlled, randomized study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):403-410. doi: 10.1111/jdv.14647. Epub 2017 Nov 15.

  PMID: 29055155 BACKGROUND

MeSH Terms

Interventions

apremilast

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be patients that have been screened within the Department of Dermatology at the GW MFA. Individuals meeting inclusion and exclusion criteria will be enrolled into the study. A total of 10 patients will be enrolled in the study and each patient will be given Apremilast 30 mg twice daily to be administered for a period of 6 months. Patients will present to clinic for clinical assessments, adverse event monitoring, laboratory testing, and/or photography at the following time periods of therapy: baseline and 2 weeks, 4 weeks, and every 4 weeks thereafter until completion of the 6 month treatment period. Additionally, all patients will be required to return for a 4-week follow up visit after completing the final dose of the study medication.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: November 15, 2018
• Study Start: February 28, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

US (1)