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Immunomodulator

open-label abatacept first, then 5 mg/kg abatacept for Uveitis

Phase 2
Waitlist Available
Led By Eric B. Suhler, MD, MPH
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343
24%
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%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PHOTODERMATOSIS
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
HEADACHE
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

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: open-label abatacept first, then 5 mg/kg abataceptExperimental Treatment1 Intervention
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
Group II: open-label abatacept first, then 10 mg/kg abataceptExperimental Treatment1 Intervention
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
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?

Oregon Health and Science UniversityLead Sponsor
1,000 Previous Clinical Trials
7,388,373 Total Patients Enrolled
7 Trials studying Uveitis
637 Patients Enrolled for Uveitis
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,125,423 Total Patients Enrolled
Eric B. Suhler, MD, MPHPrincipal InvestigatorOregon Health and Science University
~1 spots leftby Oct 2025
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