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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
Must not have
Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home
Malignancy or treated for malignancy within the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months, 12 months
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.
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.
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.
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.
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I have a specific lung condition diagnosed by a lung biopsy.
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I am 4 years old or older.
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I have been diagnosed with Common Variable Immune Deficiency.
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My lung condition has not improved or worsened, confirmed by CT scans 6 months apart.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am willing to self-administer or have someone give me injections at home.
Select...
I have been treated for cancer within the last year.
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I do not have any uncontrolled infections.
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I have not taken any immune system weakening drugs in the last 6 months.
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I have not started or increased immune drugs like azathioprine or methotrexate in the last 3 months.
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I have not taken abatacept, cyclophosphamide, TNF inhibitors, or high-dose steroids in the last 3 months.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
High Resolution CT Scan of the chest (HRCT)
Secondary study objectives
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 • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
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%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
SEBORRHOEIC KERATOSIS
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
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%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
PATELLA FRACTURE
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
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
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
~112250
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,951 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,124,983 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.
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