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VitiligoPhase 1NCT02281058

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

A Phase 1 study testing Abatacept in people with Vitiligo, run by Brigham and Women's Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
Abatacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2015to May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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.
  • Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed
  • Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication
  • Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis)
  • Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks)
  • Subjects must not be positive for hepatitis B surface antigen
  • Subjects must not be positive for HIV
  • Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay
  • Subjects with any of the following laboratory values Hemoglobin < 8.5 g/dL WBC < 3000/mm3 (< 3 x 109/L) Platelets < 100,000/mm3 (< 3 x 109/L) Serum creatinine > 2 times the ULN Serum ALT or AST > 2 times the ULN
  • Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
  • Allergies to any components of abatacept or its vehicle
  • Subjects who have at any time received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose
  • Any concomitant biologic DMARD, such as anakinra
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the detailed description

Abatacept has been shown to decrease T cell activity and reduce symptoms associated with rheumatoid arthritis. Similar pathways have been shown to be involved in vitiligo. Therefore, we are recruiting 10 adult patients with active vitiligo who meet specific inclusion and exclusion criteria to receive self-administered injections of abatacept weekly starting at week 0 and continuing until week 24. A 32 week follow-up visit will be performed to evaluate secondary endpoints as well. We will be monitoring patients to see if skin lesions of vitiligo stop spreading and start to repigment with continued treatment.

Conditions
Vitiligo
Being tested
Abatacept
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbataceptDrug

    Also called Orencia

    self-injected subcutaneous biologic medication

Study groups in NCT02281058
Study groupRoleWhat they receive
intervention groupExperimentalTen subjects recruited to self-administer abatacept 125mg injected subcutaneously weekly for 24 weeks to determine the impact it has on their vitiligo skin lesions.
Receives: Drug: Abatacept

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

Secondary outcomes (5)

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

    Measured: 32 weeks

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

    Measured: 24 weeks

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

    Measured: 32 weeks

  4. maintenance of repigmentation after stopping therapy

    Measured: 32 weeks

  5. initial time to repigmentation

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionNov 2017 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281058
Sponsor's protocol ID
2014P000699
Status last verified
Aug 2017
First submitted
29 Oct 2014
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abatacept in people with Vitiligo, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in repigmentation with abatacept therapy as measured using the Vitiligo Area and Severity Index (VASI) score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02281058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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