Open-label Pilot Study of Abatacept for the Treatment of Vitiligo

NCT02281058 | Unknown Phase 1

• 1 other identifier: 2014P000699
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo is a chronic autoimmune disease with evidence of CTLA-4 involvement. We are performing a pilot study for the treatment of new onset or actively progressing vitiligo with abatacept to determine if weekly self-injections of medication lead to clinical improvement in vitiligo lesions.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• change in repigmentation with abatacept therapy as measured using the Vitiligo Area and Severity Index (VASI) score

  24 weeks

Secondary Outcomes (5)

• clinical safety and rate of adverse events as measured by patient-reported side effects

  32 weeks

• percentage repigmentation with abatacept therapy as measured using the physician's global assessment

  24 weeks

• effect on disease-related quality of life as measured using the validated Vitiligo Quality of Life (VitiQOL) tool

  32 weeks

• maintenance of repigmentation after stopping therapy

  32 weeks

• initial time to repigmentation

  24 weeks

Study Arms (1)

intervention group

EXPERIMENTAL

Ten subjects recruited to self-administer abatacept 125mg injected subcutaneously weekly for 24 weeks to determine the impact it has on their vitiligo skin lesions.

Drug: Abatacept

Interventions

Abatacept DRUG

self-injected subcutaneous biologic medication

Also known as: Orencia

intervention group

Eligibility Criteria

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

You may qualify if:

• Non-pregnant individuals ages 18 and older with a diagnosis of actively progressive skin lesions of clinically diagnosed vitiligo covering at 5% or great body surface area (defined as development of new lesions or worsening of existing lesions within the past 6 months) not receiving immune suppressive treatment. Both subjects who have received at least one therapy in the past and subjects currently receiving treatment at the time of screening will be eligible providing they undergo a wash out period prior to starting the study (2 weeks for topical agents and systemic agents with short half lives, 1 month for phototherapy)
• Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized
• WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 48 hours before the first dose of study drug
• Women must not be breast-feeding
• Sexually active fertile men must use effective birth control if their partners are WOCBP

You may not qualify if:

• Pregnant or breastfeeding patients
• Patients with segmental, acrofacial, or universal vitiligo
• Patients with evidence of poliosis (white hairs) within the majority (\>50%) of their vitiligo lesions
• Patients currently on any other systemic biologic medication, current use of Abatacept, or any other systemic biologic medication within 2 months of study (or within 5 half-lives of last dose of drug)
• Use of systemic immunosuppressive agent within 2 weeks prior to initiation of Abatacept
• Use of potent topical steroids, topical tacrolimus or pimecrolimus within 2 weeks prior to initiation of Abatacept
• Use of phototherapy within one month prior to initiation of Abatacept therapy
• Patients with a history of chronic obstructive pulmonary disease
• History of active Mycobacterium tuberculosis infection (any subspecies) Use of any investigational medication within 28 days prior to enrollment or 5 half-lives if known (whichever is longer)
• Receiving concomitant immune modulating therapy (see concomitant medications, section 8.6). Subjects receiving such agents at screening may be eligible to enroll following a washout period of 2 weeks for topical agents and systemic agents with short half lives
• Subjects who are impaired, incapacitated, or incapable of completing study-related assessments
• Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to vitiligo and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
• Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ. Existing non-melanoma skin cell cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug
• Subjects who currently abuse drugs or alcohol
• Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 3, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: May 1, 2018
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

US (1)