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Proteasome Inhibitor
Ixazomib for Scleroderma-Related Lung Disease
Phase 2
Recruiting
Led By Leroy Griffing, MD
Research Sponsored by W. Leroy Griffing
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scleroderma skin thickness score (modified Rodnan skin score) between 15 and 45
Confirmed diagnosis of diffuse cutaneous systemic sclerosis/scleroderma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
Study Summary
This trial is testing a new medication for scleroderma/systemic sclerosis to see if it is safe and effective.
Who is the study for?
Adults over 18 with a confirmed diagnosis of diffuse cutaneous systemic sclerosis/scleroderma, experiencing lung involvement but without severe heart or kidney issues, not currently smoking, and who haven't had certain treatments like stem cell transplants. Participants should have stable disease without expectation of needing to drop out due to other health problems.Check my eligibility
What is being tested?
The trial is testing the oral medication Ixazomib for its safety and effects on skin, lungs, and overall health in scleroderma-related lung disease patients. It aims to understand how well patients tolerate this drug and its impact on their quality of life.See study design
What are the potential side effects?
Ixazomib may cause side effects such as gastrointestinal issues (like nausea), blood count abnormalities (affecting red or white cells), potential liver function changes, nerve damage (neuropathy), and could worsen any existing infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin thickness score for scleroderma is between 15 and 45.
Select...
I have been diagnosed with diffuse cutaneous systemic sclerosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal 2.0 (UCLA SCTC GIT 2.0) questionnaire score
Number of participants with at least one treatment-emergent adverse event (AE)
Number of participants with treatment-emergent AEs leading to ixazomib dose modifications.
+1 moreSecondary outcome measures
Change from baseline in Modified Rodnan Skin Score (MRSS)
Change from baseline in high resolution chest CT scan Goh score
Diffuse Scleroderma
+7 moreSide effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637429%
Diarrhoea
24%
White blood cell count decreased
20%
Platelet count decreased
16%
Rash
16%
Neutrophil count decreased
11%
Pneumonia
9%
Constipation
9%
Malaise
9%
Pyrexia
9%
Anaemia
9%
Nasopharyngitis
7%
Decreased appetite
7%
Taste disorder
4%
Acute kidney injury
4%
Influenza
2%
Bile duct stone
2%
Gastroenteritis
2%
Pneumonia bacterial
2%
Bone pain
2%
Febrile neutropenia
2%
Duodenal ulcer
2%
Enterocolitis
2%
Tibia fracture
2%
Interstitial lung disease
2%
Prinzmetal angina
2%
Compression fracture
2%
Spinal compression fracture
2%
Tumour lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
[Overall]; Combination Therapy + Ixazomib Therapy
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ixazomib in patients with scleroderma-interstitial lung disease (ILD)Experimental Treatment1 Intervention
Participants will be administered oral ixazomib for six cycles (each cycle is 28 days duration).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370
Find a Location
Who is running the clinical trial?
W. Leroy GriffingLead Sponsor
Leroy Griffing, MD5.011 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic
5Patient Review
I felt extremely confident in this doctor's ability after our consultation. They have excellent bedside manner and made sure I was comfortable with the information they were sharing with me. I would definitely recommend them to anyone seeking a great physician.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood disorder that is not chronic anemia or iron deficiency.My skin thickness score for scleroderma is between 15 and 45.I haven't had any cancer except for non-melanoma skin cancer or a localized carcinoma in the last 5 years.My condition started less than 5 years ago, not counting Raynaud's phenomenon.I have been diagnosed with diffuse cutaneous systemic sclerosis.I expect to pause the study due to upcoming medical or surgical needs.I agree to stop all other scleroderma-related lung disease treatments except mycophenolate for the first 90 days.I am following birth control measures or practicing abstinence as required.I am following the required birth control measures or practicing abstinence during and for 90 days after the study.My heart's pumping ability is reduced, with an ejection fraction below 40%.I have used rituximab before.I have a narrowing in my esophagus that makes it hard to swallow pills.My kidneys are not working well, with a creatinine clearance below 30 mL/min.I have previously taken ixazomib or similar medications.I have used cyclophosphamide before.I am not using medications that strongly affect liver enzyme activity.I haven't had serious heart problems or hospital visits for heart issues in the last 6 months.You have severe stomach or digestive system problems caused by scleroderma, as determined by a specific questionnaire.You have smoked tobacco within the last 3 months or are not willing to stop smoking during the study.You have a condition that is very likely to cause death within the next year.I have a known blood cancer.My recent chest CT shows signs of scleroderma in my lungs.I have had a stem cell or bone marrow transplant.I am receiving treatment for high blood pressure in the lungs.My liver tests show significant abnormalities.I have a connective-tissue disorder like rheumatoid arthritis or lupus.Your lung function test shows that your lungs are working well enough.I have had a scleroderma renal crisis before.I do not have severe nerve damage that could worsen with ixazomib treatment.You have had problems with drinking alcohol or using drugs in the past 2 years.I do not have any active infections like bronchitis or UTI.You might have a bad reaction to ixazomib or any of the other ingredients in the medication.I am currently using or will use certain medications that affect my immune system or blood pressure.I am 18 years or older and have given my written consent.My mycophenolate dose has been the same for the last 3 months.I do not have severe lung problems like COPD, emphysema, or serious asthma.I am willing to stop taking certain medications under supervision for the first 90 days of the study.I have been exposed to substances or environments that can cause lung scarring.My heart scan in the last 6 months showed no signs of high blood pressure in the lungs.I have or might have an active stomach ulcer.Your blood counts show low levels of hemoglobin, white blood cells, or platelets.I have a known liver condition like hepatitis or cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib in patients with scleroderma-interstitial lung disease (ILD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Have any other investigations explored the efficacy of Ixazomib?
"Presently, 69 enquiries into Ixazomib are active with 7 in their final phase of research. Most of the trials for this drug occur in Cleveland, OH but there is a network of 2057 medical sites conducting studies on its efficacy."
Answered by AI
Is this healthcare study currently seeking participants?
"Affirmative. According to clinicaltrials.gov, the medical trial posted on April 28th 2021 is currently enrolling participants and 12 patients are required at 1 location before it can commence. The last time this study was updated was May 3rd 2022."
Answered by AI
What is the upper limit of individuals enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting patients since April 28th 2021 and the last update was on May 3rd 2022. The aim of the study is to recruit a total of 12 participants from 1 research centre."
Answered by AI
Has the FDA sanctioned Ixazomib for therapeutic use?
"The safety of Ixazomib was estimated at a 2 out of 3, as the current Phase 2 trial does not yet have sufficient evidence to support efficacy."
Answered by AI
What are the aims of this research project?
"This trial's primary aim is to ascertain the amount of participants experiencing treatment-emergent adverse events necessitating an ixazomib dose adjustment within a period of 7 months. Secondary assessments include changes in American College of Rheumatology Composite Response Index for clinical trials in early diffuse cutaneous Systemic Sclerosis (ACR CRISS), forced vital capacity (FVC) and diffusion capacity (DLCO) % predicted, as well as Dyspnea Status Rating via Mahler Transitional Dyspnea Index."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long does it last? Do I have to travel, if so for how long?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’m trying to save my life. The medication they are wanting me to take have horrible side effects and I also have stage 3CKD and heart disease.
PatientReceived no prior treatments
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