Your session is about to expire
← Back to Search
Immunomodulator
Abatacept for Interstitial Lung Disease (ABCVILD Trial)
Phase 2
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months, 12 months
Awards & highlights
ABCVILD Trial Summary
This trial is looking at whether abatacept is effective for treating granulomatous-lymphocytic interstitial lung disease in people with common variable immunodeficiency.
Who is the study for?
This trial is for people aged 4 and above with Common Variable Immunodeficiency (CVID) and a specific lung condition diagnosed by biopsy. Participants must have been on immunoglobulin replacement for at least 6 months, agree to birth control if necessary, and consent to future use of their biological samples. Exclusions include recent cancer treatment, uncontrolled infections, certain drug treatments within the past few months, chronic hepatitis B or C, HIV infection, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study tests Abatacept's effectiveness against a placebo in treating interstitial lung disease associated with CVID. It's a phase II trial involving multiple sites where participants are randomly assigned to receive either Abatacept or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Abatacept may cause side effects such as headache, nausea, mild infections like colds or urinary tract infections. There could also be injection site reactions including redness and pain.
ABCVILD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on immunoglobulin replacement for 6+ months and will continue it.
Select...
I have a specific lung condition diagnosed by a lung biopsy.
Select...
I am 4 years old or older.
Select...
I have been diagnosed with Common Variable Immune Deficiency.
Select...
My lung condition has not improved or worsened, confirmed by CT scans 6 months apart.
ABCVILD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
High Resolution CT Scan of the chest (HRCT)
Secondary outcome measures
Additional Immune Agents
Adverse Events/Serious Adverse Events
Change in King's Interstitial Lung Disease scores
+15 moreSide effects data
From 2023 Phase 3 trial • 613 Patients • NCT030863436%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg
ABCVILD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AbataceptExperimental Treatment1 Intervention
Pediatric subjects weighing <50 kg will be placed in an single arm with abatacept with dosing based on weight. Pediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through weekly 26.
Pediatric dosing:
Abatacept subcutaneous every week:
10-25 kg: 50 mg; 25-50 kg: 87.5 mg; >50 kg: 125 mg
Adult dosing:
Abatacept: 125 mg subcutaneous every week
Group II: PlaceboPlacebo Group1 Intervention
Pediatric subjects weighing ≥50kg and adult subjects will enter a double blinded, randomization in a 1:2 ratio of subjects to the abatacept treatment group (arm 1) or to the placebo group (arm 2) treated weekly through weekly 26. The composition of the placebo is the same as the active study drug without the abatacept. To maintain the blind, injection volumes will be the same as the active treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112150
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,553 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,426 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an unusual reaction to vaccines.You have a history of testing positive for HIV.I have been on immunoglobulin replacement for 6+ months and will continue it.I have a specific lung condition diagnosed by a lung biopsy.I am a man who can father children and will use condoms during and for 3 months after the study.You have untreated chronic hepatitis B or C, confirmed by a positive PCR test.You have a weakened immune system that was caused by another health condition.I am willing to self-administer or have someone give me injections at home.You have a high level of Epstein-Barr Virus in your blood that has been checked twice at least a month apart.I have been treated for cancer within the last year.I do not have any uncontrolled infections.I do not have active TB, or I have completed treatment for latent TB.I have not taken any immune system weakening drugs in the last 6 months.Low levels of IgA and/or IgM in the blood.I have not started or increased immune drugs like azathioprine or methotrexate in the last 3 months.I am 4 years old or older.You have had a bad reaction to abatacept or any of its parts in the past.Your blood test shows low levels of a specific type of antibody called IgG.I have not taken abatacept, cyclophosphamide, TNF inhibitors, or high-dose steroids in the last 3 months.I have been diagnosed with Common Variable Immune Deficiency.You are expected to live for less than one month.I am using or agree to use an effective form of birth control.I have not received a live vaccine in the last 6 weeks.My lung condition has not improved or worsened, confirmed by CT scans 6 months apart.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Abatacept
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any dangers associated with Abatacept?
"There is some data supporting the safety of Abatacept, but none yet for efficacy. We've given it a score of 2."
Answered by AI
What are some of the most popular reasons that doctors prescribe Abatacept?
"Abatacept is a medication prescribed to patients with rheumatoid arthritis. It's also used to mitigate the symptoms of psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."
Answered by AI
Are there still places available for people who want to participate in this research?
"Yes, as of 9/9/2022 this trial is still looking for participants. The listing was created on 7/14/2021."
Answered by AI
Are there any other similar cases in which Abatacept has been used?
"Currently, there are 36 ongoing studies investigating abatacept. 8 of those trials have reached Phase 3 clinical testing. The majority of these investigations into abatacept's efficacy are taking place in Toronto, but there are a total of 772 research sites worldwide."
Answered by AI
How many people are signing up to be a part of this test group?
"Yes, as specified on clinicaltrials.gov, this study is recruiting patients. The trial was posted on 7/14/2021 and updated on 9/9/2022. They are looking for 60 participants from 1 site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger