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CTLA-4 Inhibitor
intervention group for Vitiligo
Phase 1
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
COVID-19
15%
URINARY TRACT INFECTION
14%
NASOPHARYNGITIS
11%
UPPER RESPIRATORY TRACT INFECTION
10%
RHEUMATOID ARTHRITIS
9%
HYPERTENSION
9%
HERPES ZOSTER
7%
BACK PAIN
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
NAUSEA
6%
BRONCHITIS
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
COUGH
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
ARTHRALGIA
5%
WEIGHT INCREASED
5%
HYPERCHOLESTEROLAEMIA
4%
HEADACHE
4%
INFLUENZA
4%
OSTEOARTHRITIS
4%
FALL
4%
DEPRESSION
4%
ANAEMIA
3%
NEUTROPENIA
3%
COVID-19 PNEUMONIA
3%
EAR INFECTION
3%
SPINAL OSTEOARTHRITIS
3%
VITAMIN D DEFICIENCY
3%
CYSTITIS
3%
RESPIRATORY TRACT INFECTION
3%
PHARYNGITIS
3%
SINUSITIS
3%
GREATER TROCHANTERIC PAIN SYNDROME
3%
DIARRHOEA
3%
VOMITING
3%
FATIGUE
3%
PYREXIA
3%
HEPATIC STEATOSIS
3%
GASTROENTERITIS
2%
ANXIETY
2%
GASTRITIS
2%
LATENT TUBERCULOSIS
2%
PNEUMONIA
2%
INSOMNIA
2%
SCIATICA
2%
DYSPEPSIA
1%
MITRAL VALVE INCOMPETENCE
1%
DERMATITIS ALLERGIC
1%
HIP FRACTURE
1%
IRON DEFICIENCY ANAEMIA
1%
BLOOD PRESSURE INCREASED
1%
CARPAL TUNNEL SYNDROME
1%
PULMONARY MASS
1%
PRURITUS
1%
CATARACT
1%
ABDOMINAL PAIN
1%
MUSCULOSKELETAL CHEST PAIN
1%
PARAESTHESIA
1%
SYNCOPE
1%
SEPTIC SHOCK
1%
PULMONARY EMBOLISM
1%
TOOTH INFECTION
1%
TOOTH FRACTURE
1%
PHARYNGITIS STREPTOCOCCAL
1%
VIRAL UPPER RESPIRATORY TRACT INFECTION
1%
ATRIAL FIBRILLATION
1%
PLEURAL EFFUSION
1%
TACHYCARDIA
1%
TINNITUS
1%
PERIPHERAL SWELLING
1%
ASYMPTOMATIC COVID-19
1%
HERPES SIMPLEX
1%
PERIODONTITIS
1%
CONTUSION
1%
BLOOD CREATININE INCREASED
1%
BLOOD TRIGLYCERIDES INCREASED
1%
HAEMOGLOBIN DECREASED
1%
HEPATIC ENZYME INCREASED
1%
LIVER FUNCTION TEST INCREASED
1%
OSTEOPENIA
1%
DIZZINESS
1%
RENAL CYST
1%
DYSPHONIA
1%
NASAL CONGESTION
1%
RHINORRHOEA
1%
COSTOCHONDRITIS
1%
MUSCLE SPASMS
1%
OSTEOPOROSIS
1%
ASTHMA
1%
DEVICE DISLOCATION
1%
TRICUSPID VALVE INCOMPETENCE
1%
GLAUCOMA
1%
CONSTIPATION
1%
CHOLELITHIASIS
1%
LOCALISED INFECTION
1%
ONYCHOMYCOSIS
1%
ORAL CANDIDIASIS
1%
DECREASED APPETITE
1%
DIABETES MELLITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Trial Design
1Treatment groups
Experimental Treatment
Group I: intervention groupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,491,025 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,635 Total Patients Enrolled
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