CLINICAL TRIALS

Alopecia areata (AA) is a chronic inflammatory disease characterized by non-scarring immune-mediated hair loss. AA typically presents as patches of hair loss in the scalp, but can progress to hair loss involving the entire scalp (alopecia areata totalis), or the entire body (alopecia areata universalis). Although AA is often considered a benign condition, it can cause significant emotional and psychosocial distress, especially in younger populations. There are currently no FDA approved treatments for AA and treatment regimens for patients with moderate to severe disease are often unsatisfactory.

This is a randomized control trial that aims to test a new investigational oral medication called CTP-543 in patients with moderate to severe AA. The study will take place over the course of 28 weeks. During that time those enrolled will take either the active study medication or a placebo twice a day and report to the research center on UCI main campus for regular physical exams, blood tests, and distribution of the medication. Participants must be between the ages of 18 and 65 years, must not be pregnant, or taking any immunosuppressive medications. The information collected from this study will be used to better understand the effects of CTP-543 on patients with AA and help researchers continue to develop new therapies in the future.

Study title: A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients with Moderate to Severe Alopecia Areata

Research Qualifications

Psoriasis is a chronic inflammatory skin disease characterized by pink to red, scaly patches usually on the elbows and knees. Psoriasis may progress to involve multiple parts of the body, including the trunk, scalp, nails and intertriginous areas, and may even cause systemic symptoms such as joint pain especially of the hands and feet. Unfortunately, this autoimmune disease may cause significant psychosocial stress to patients, especially children and adolescents.

Psoriasis treatment consists of symptom control, decreasing inflammation, and possibly even systemic immunosuppression for severe cases. The first-line treatment for psoriasis often involves the use of topical emollients, corticosteroids, and corticosteroid-sparing agents. Betamethasone is a topical corticosteroid that is often prescribed in the form of lotion, cream or ointment. In children and adolescents, the long-term use of topical corticosteroids may influence the release of the body’s own physiologic steroids.

This clinical trial aims to characterize the use of a new topical betamethasone dispropionate spray formulation in adolescents with moderate to severe plaque psoriasis. Subjects will be randomized to receive treatment for either 15 days or 29 days. During this time, patients will apply corticosteroid spray to affected psoriatic lesions twice daily and report to the research center on UCI Main Campus for regular physical exams and blood tests to help to determine the status of the body’s own steroid production. Participants must be between the ages of 12-16.9 years, must not be pregnant, must not be taking any systemic immunosuppressive or psoriatic therapeutics, and must not be currently applying topical treatments including corticosteroids. The information collected from this study will be used to better understand the use of topical corticosteroid preparations in the adolescent population and help researchers to develop new modalities of delivery for topical therapies for psoriasis.

Systemic lupus erythematosus (SLE) is a chronic, inflammatory, autoimmune disease that affects multiple organ systems throughout the body including the joints, muscles, kidneys, heart, lungs and brain. Depending on their specific lupus subtype, patients may or may not present with skin manifestations. It is also possible for patients to only have skin manifestations without systemic involvement. Patients affected by lupus are often left with a large burden of disease, including emotional and psychological distress. Currently, treatments approved for lupus are limited and associated with dangerous side effects.

This is a randomized, placebo-controlled trial that will test an investigational injectable medication called BIIB059 in SLE patients with skin manifestations (Part A), as well as cutaneous lupus patients with or without systemic manifestations of disease (Part B). The study will take place over either 24 weeks (Part A) or 16 weeks (Part B). During this time patients will either receive active study drug or placebo when they report to the UCI Dermatology Clinical Research Center located at the Main Campus. In addition to receiving investigational drug, patients will also be required to undergo physical exams, blood tests, EKGs, and participate in questionnaires meant to monitor disease progression while in the study. Participants must be between the ages of 18-75 years old, must not be pregnant, and must not be taking any biologic agent. Patients will be allowed to continue their systemic corticosteroids or immunomodulating therapies, as long as their dose has been stable for four weeks prior to study involvement. The data collected during this study will be used to understand the effects and confirm the safety of BIIB059 in patients with lupus, as well as help future development of biologic therapies for lupus treatment.

Vitiligo is seen in 0.5-2% of the general population worldwide1. It is a disorder characterized by the loss of melanocytes that results in depigmentation of the skin so that it appears white. Vitiligo is more than a cosmetic disorder as substantiated by numerous studies that demonstrate a profound burden on patients’ quality of life.2 Patients with vitiligo suffer from low self-esteem, negative perception of body image, and social isolation.3 Additionally, depression is prevalent among vitiligo sufferers.

You can participate in this study if you are:

• Any genders, social/ethnic groups aged 11+ who are able to complete the requested survey.
• Subjects must be undergoing or initiating treatment for vitiligo.
• Subjects undergoing medical therapy, including topical steroids, calcineurin inhibitors, pulse dose oral or systemic steroids, and JAK inhibitors will serve as the control group
• Patients must have vitiligo involvement of the hands and face or a VES score, a score quantifying vitiligo skin involvement that will be determined by your healthcare provider, of greater than or equal to 25%, irrespective of anatomical involvement.

You cannot participate in this study if you:

• Planning to stop medical therapy within 3 months (study’s first follow-up interval)

Subjects will undergo phototherapy and receive appropriate online surveys at each follow-up at an interval of 3 months for the course of 6 months.

The purpose of this research study is to establish a correlation between clinical improvement in vitiligo depressive symptoms following phototherapy in patients with vitiligo. This study is vital as it is the first to establish the psychosocial benefit of this treatment modality, to rationalize appropriate referrals and to justify insurance funding of this necessary resource.

1-Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84.

2-Ongenae K, van Geel N, De Schepper S et al. Effect of vitiligo on self-reported health-related quality of life. Br J Dermatol. 2005;152:1165–1172.

3- Kent G, Al'Abadie M. Factors affecting responses on Dermatology Life Quality Index items among vitiligo sufferers Clin Exp Dermatol 1996; 21-330