intervention group for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VitiligoAbatacept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 32 weeks

24 weeks
change in repigmentation with abatacept therapy as measured using the Vitiligo Area and Severity Index (VASI) score
initial time to repigmentation
percentage repigmentation with abatacept therapy as measured using the physician's global assessment
32 weeks
clinical safety and rate of adverse events as measured by patient-reported side effects
effect on disease-related quality of life as measured using the validated Vitiligo Quality of Life (VitiQOL) tool
maintenance of repigmentation after stopping therapy

Trial Safety

Safety Progress

1 of 3

Side Effects for

IV ABATACEPT
85%NASOPHARYNGITIS
60%PHARYNGITIS
50%INFLUENZA
35%STOMATITIS
35%LIGAMENT SPRAIN
35%HEADACHE
30%CONTUSION
30%UPPER RESPIRATORY TRACT INFLAMMATION
25%DIARRHOEA
25%ACNE
25%ARTHRALGIA
25%SEASONAL ALLERGY
25%BRONCHITIS
20%PYREXIA
20%UPPER RESPIRATORY TRACT INFECTION
20%NAUSEA
20%GASTROENTERITIS
15%EPISTAXIS
15%VOMITING
15%RHINITIS ALLERGIC
15%VIRAL PHARYNGITIS
15%RHINITIS
15%COUGH
15%SKIN PAPILLOMA
15%CONJUNCTIVITIS
15%RASH
10%PURPURA
10%DERMATITIS
10%PAIN IN EXTREMITY
10%TOOTHACHE
10%MYALGIA
10%TENDONITIS
10%CONSTIPATION
10%ABDOMINAL PAIN UPPER
10%ARTHROPOD BITE
10%JUVENILE IDIOPATHIC ARTHRITIS
10%ANGULAR CHEILITIS
10%SKIN ABRASION
10%DRY EYE
10%ABDOMINAL PAIN
10%APHTHOUS ULCER
10%ALOPECIA
10%BACK PAIN
10%DRY SKIN
10%INFLUENZA B VIRUS TEST POSITIVE
10%ENTEROCOLITIS VIRAL
10%RHINORRHOEA
10%ECZEMA
5%VARICELLA
5%VIRAL TONSILLITIS
5%LOWER LIMB FRACTURE
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT01835470) in the IV ABATACEPT ARM group. Side effects include: NASOPHARYNGITIS with 85%, PHARYNGITIS with 60%, INFLUENZA with 50%, STOMATITIS with 35%, LIGAMENT SPRAIN with 35%.

Trial Design

1 Treatment Group

intervention group
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: intervention group · No Placebo Group · Phase 1

intervention group
Drug
Experimental Group · 1 Intervention: Abatacept · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 32 weeks

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,317 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,480 Previous Clinical Trials
9,735,815 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Connecticut100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Brigham and Women's Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%