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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
ACUTE RESPIRATORY FAILURE
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
URINARY TRACT INFECTION
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
12%
RASH
12%
WEIGHT INCREASED
6%
PATELLA FRACTURE
6%
HYPONATRAEMIA
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
SEBORRHOEIC KERATOSIS
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
SWELLING
6%
BLOOD PRESSURE INCREASED
6%
RHEUMATOID ARTHRITIS
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PHOTODERMATOSIS
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
HEADACHE
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HAEMOGLOBIN DECREASED
6%
PNEUMONIA BACTERIAL
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
STAPHYLOCOCCAL INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
6%
FEELING HOT
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
COUGH
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
PERIPHERAL SWELLING
6%
ORAL CANDIDIASIS
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
FLANK PAIN
6%
PARAESTHESIA
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
CONSTIPATION
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/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: 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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,658 Previous Clinical Trials
11,699,562 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,680 Previous Clinical Trials
4,124,893 Total Patients Enrolled
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