A Phase 2 interventional study of Ixazomib in Systemic Sclerosis, Scleroderma and Diffuse Systemic Sclerosis, sponsored by Michael M. Pham. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Michael M. Pham · Phase 2, Interventional, and Treatment
Among 153 studies in Scleroderma, Diffuse with a site in United States — 29 open to participants now, 39 under way, 5 of them phase 3. Scleroderma, Diffuse · United States.
Among the 153 studies in Scleroderma, Diffuse with a site in United States, this one is the 108th largest by enrollment of the 120 interventional ones that give a count, is one of 10 that started in 2021, is one of 41 in phase 2, and was the 111th registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →29 of the 153 studies in Scleroderma, Diffuse with a site in United States are open now. Recruiting first, the newest first:
Miltenyi Biomedicine GmbH · Sites in United States
Mediar Therapeutics · Sites in United States, Australia, France and 7 more countries
Galderma R&D · Sites in United States, Switzerland
Allogene Therapeutics · Sites in United States, Canada
Boston University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 62 · Phase 3 18 · Phase 4 2
First in 1992; this study’s year is marked. 10 started in 2021.
This study's enrollment of 4 is below the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 29 across the 120 interventional studies, 197 across the 32 observational. Of the 100 that completed or were terminated, 40 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
61 of 153 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Michael M. Pham as lead sponsor.
Michael M. Pham has 1 study filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
8 of the studies in Scleroderma, Diffuse with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT03276923Duke UniversityMaternal Autoimmune Disease Research Alliance (MADRA) Registry | 2027-01-01 |
| NCT06152172David PorterCARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 | 2027-02 |
| NCT06843239Zura Bio IncTibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) | 2027-05 |
Among the 153 studies in Scleroderma, Diffuse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.
The primary objective of this study is to assess the safety and tolerability of oral ixazomib taken on days 1, 8, and 15 of each 28-day treatment cycle for 6 cycles in 12 participants having diffuse systemic sclerosis/scleroderma of less than 5 years duration with non-severe interstitial lung involvement as identified from chest CT scan completed within the preceding 3 months or at study screening visit. All 12 participants will receive oral ixazomib. Reflecting the common use of mycophenolate in the management of scleroderma with complicating interstitial lung disease, 6 of 12 participants who will be enrolled will be already taking mycophenolate at a stable dose for the preceding 3 months and will be allowed to continue taking mycophenolate throughout the entire study prescribed as routine care. Ixazomib will be added to their medications. The remaining 6 of 12 participants meeting the same eligibility criteria will not be using mycophenolate or any other treatment for scleroderma interstitial lung disease at the time of enrollment and will subsequently take ixazomib study medication during participation in this study. Ixazomib dose modification or interruption is allowed for safety and tolerability reasons at any time during the study.
The secondary objective of this study is to assess the effect of ixazomib on scleroderma skin tightness/thickening and its effect on scleroderma interstitial lung disease.
The study includes approximately 13 clinic visits over up to approximately 10 months. Study procedures include medical examinations, blood tests, chest CT scans, pulmonary function tests, echocardiogram, EKG, skin biopsies, and questionnaires.
There is no cost for participation in this study.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →This is the only study on the registry with Michael M. Pham as lead sponsor.
Compared within Scleroderma, Diffuse, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Scleroderma, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered oral ixazomib for six cycles (each cycle is 28 days duration).
Drug: Ixazomib
Ixazomib 4 mg capsule taken orally on days 1, 8, and 15 of a 28-day treatment cycle repeated for 6 cycles
Treatment-emergent Adverse Event (AE)
The number of participants with at least one treatment-emergent adverse event. Defined as any of the following: Treatment-emergent AEs; Treatment-emergent serious adverse events (SAEs); Treatment-emergent treatment-related AEs; or Treatment-emergent treatment-related SAEs.
Time frame: 7 months
Adverse Events Leading to Ixazomib Dose Modifications
Number of participants with treatment-emergent AEs leading to ixazomib dose modifications.
Time frame: 7 months
Adverse Events Leading to Ixazomib Early Discontinuation
Number of participants with treatment-emergent AEs leading to ixazomib early discontinuation.
Time frame: 7 months
Change in the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal 2.0 (UCLA SCTC GIT 2.0) Questionnaire Score
The UCLA SCTC GIT 2.0 is a self-administered survey consisting of 34 questions (Reflux 1 to 8, Distention/Bloating 9 to 12, Fecal Soilage 13, Diarrhea 14 to 15, Social functioning 16 to 21, Emotional well-being 22 to 30, Constipation 31 to 34). The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health, except for questions 15 and 31, which are scored as 0 (better health) and 1 (worse health). Scores from all scales except the constipation scale are averaged to form a total GIT score from 0 (no gastrointestinal problems) to 3 (most severe) that captures overall burden of severity of scleroderma-associated gastrointestinal involvement.
Time frame: Baseline, 7 months
Change From Baseline in Modified Rodnan Skin Score (MRSS)
MRSS is a validated clinical semiquantitative assessment of scleroderma skin thickness at 17 prespecified sites on the body, with thickness at each site scored from 0 (uninvolved) to 3 (severe thickening) that are tabulated for a total numerical skin score ranging 0-51. Lower scores indicate less involvement, and higher scores indicate more severe thickening.
Time frame: Baseline, 24 weeks
Change From Baseline in High Resolution Chest CT Scan Goh Score
Staging extent of scleroderma lung involvement on high resolution chest CT scan by the application of Goh criteria which identified a severity extent threshold of 20% lung involvement yields two cohorts with significantly different 10 year survivorship. Goh scores range 0-100% with a higher score indicating greater extent of lung involvement.
Time frame: Baseline, 24 weeks
Change in Forced Vital Capacity (FVC) % Predicted.
FVC is the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath.
Time frame: Baseline, 7 months
Change in Total Lung Capacity (TLC) % Predicted
TLC is the total maximum amount of air that lungs can hold.
Time frame: Baseline, 24 weeks
Severity of Dyspnea at Baseline (Mahler Baseline Dyspnea Index)
Severity of dyspnea at baseline is measured with the Mahler Baseline Dyspnea Index (BDI). BDI includes 5 grades of severity from 0 (severe impairment) to 4 (no impairment ) for each of 3 categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (0-12). Higher scores indicate lower impairment.
Time frame: Baseline
Dyspnea Status Rating (Mahler Transitional Dyspnea Index)
Mahler Transitional Dyspnea Index (TDI) rates a participant's dyspnea status relative to baseline. TDI scores range from -3 (major deterioration) to +3 (major improvement) including 0 to indicate no change in status for each of the 3 BDI categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (-9 to +9). Higher scores indicate major improvement.
Time frame: 12 weeks, 24 weeks
Change in Scleroderma Health Assessment Questionnaire (SHAQ) Score
SHAQ self-assesses function in 8 domains of the Health Assessment Questionnaire Disability Index (HAQ-DI): dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Highest domain scores 0 (no difficulty) to 3 (unable to do) are summed and divided by 8 to yield Disability Index score as a continuous variable ranging 0 to 3. SHAQ has:1) a 15-cm Visual Analog Scale (VAS) rating pain with anchors "No Pain" and "Very Severe Pain"; 2) four 15-cm VAS assessing Raynaud phenomenon, digital ulcers, gastrointestinal and lung symptoms with anchors "Does Not Interfere" and "Very Severe Limitation"; and 3) overall disease severity 15-cm VAS with anchors "No Disease" and "Very Severe Disease"
Time frame: Baseline, 24 weeks
Change in Patient Global Assessment of Disease Activity (PtGA)
Patient-reported outcome that represents the participant's assessment of his or her current overall health (Question: How was your overall health in the last week?) rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage.
Time frame: Baseline, 24 weeks
Change in Physician Global Assessment of Disease Activity (MDGA)
Physician-reported outcome that represents an assessment of the participant's current overall health rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage.
Time frame: Baseline, 24 weeks
Change in American College of Rheumatology Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis (ACR CRISS)
ACR CRISS calculates the predicted probability of improvement in a 2-step process. Four possible outcomes in Step 1 include worsening of FVC % predicted by at least 15%, new decline of left ventricular ejection fraction to 45% or less attributable to scleroderma and needing treatment, new onset pulmonary arterial hypertension attributable to scleroderma and scleroderma renal crisis. If any one of these outcomes develops as a change from baseline, the participant is classified as not improved (score = 0) regardless of changes in other parameters. Step 2 calculates change from baseline in the predicted probability of improvement based on combined changes in the mRSS, FVC % predicted, patient global assessment, physician global assessment, and HAQ-DI. The calculated probability ranges from 0 (not improved) to 1.0 where a higher score indicates improvement.
Time frame: Baseline, 24 weeks
Change in Diffusion Capacity (DLCO) % Predicated
DLCO is the amount of carbon monoxide (CO) that moves from the lungs to the blood
Time frame: Baseline, 7 months
| Milestone | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol violation | 1 |
The number of participants with at least one treatment-emergent adverse event. Defined as any of the following: Treatment-emergent AEs; Treatment-emergent serious adverse events (SAEs); Treatment-emergent treatment-related AEs; or Treatment-emergent treatment-related SAEs.
| Participants | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Treatment-emergent Adverse Event (AE) | 3 |
Number of participants with treatment-emergent AEs leading to ixazomib dose modifications.
| Participants | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Adverse Events Leading to Ixazomib Dose Modifications | 2 |
Number of participants with treatment-emergent AEs leading to ixazomib early discontinuation.
| Participants | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Adverse Events Leading to Ixazomib Early Discontinuation | 2 |
The UCLA SCTC GIT 2.0 is a self-administered survey consisting of 34 questions (Reflux 1 to 8, Distention/Bloating 9 to 12, Fecal Soilage 13, Diarrhea 14 to 15, Social functioning 16 to 21, Emotional well-being 22 to 30, Constipation 31 to 34). The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health, except for questions 15 and 31, which are scored as 0 (better health) and 1 (worse health). Scores from all scales except the constipation scale are averaged to form a total GIT score from 0 (no gastrointestinal problems) to 3 (most severe) that captures overall burden of severity of scleroderma-associated gastrointestinal involvement.
| score on a scale | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal 2.0 (UCLA SCTC GIT 2.0) Questionnaire Score | -0.09 ± 0.156 |
MRSS is a validated clinical semiquantitative assessment of scleroderma skin thickness at 17 prespecified sites on the body, with thickness at each site scored from 0 (uninvolved) to 3 (severe thickening) that are tabulated for a total numerical skin score ranging 0-51. Lower scores indicate less involvement, and higher scores indicate more severe thickening.
| score on a scale | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change From Baseline in Modified Rodnan Skin Score (MRSS) | -4.33 ± 11.02 |
Staging extent of scleroderma lung involvement on high resolution chest CT scan by the application of Goh criteria which identified a severity extent threshold of 20% lung involvement yields two cohorts with significantly different 10 year survivorship. Goh scores range 0-100% with a higher score indicating greater extent of lung involvement.
No measurements were reported for this outcome.
FVC is the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath.
| percentage of air | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in Forced Vital Capacity (FVC) % Predicted. | -0.33 ± 5.51 |
TLC is the total maximum amount of air that lungs can hold.
| percentage of air in lungs | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in Total Lung Capacity (TLC) % Predicted | 5 ± 39.11 |
Severity of dyspnea at baseline is measured with the Mahler Baseline Dyspnea Index (BDI). BDI includes 5 grades of severity from 0 (severe impairment) to 4 (no impairment ) for each of 3 categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (0-12). Higher scores indicate lower impairment.
No measurements were reported for this outcome.
Mahler Transitional Dyspnea Index (TDI) rates a participant's dyspnea status relative to baseline. TDI scores range from -3 (major deterioration) to +3 (major improvement) including 0 to indicate no change in status for each of the 3 BDI categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (-9 to +9). Higher scores indicate major improvement.
No measurements were reported for this outcome.
SHAQ self-assesses function in 8 domains of the Health Assessment Questionnaire Disability Index (HAQ-DI): dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Highest domain scores 0 (no difficulty) to 3 (unable to do) are summed and divided by 8 to yield Disability Index score as a continuous variable ranging 0 to 3. SHAQ has:1) a 15-cm Visual Analog Scale (VAS) rating pain with anchors "No Pain" and "Very Severe Pain"; 2) four 15-cm VAS assessing Raynaud phenomenon, digital ulcers, gastrointestinal and lung symptoms with anchors "Does Not Interfere" and "Very Severe Limitation"; and 3) overall disease severity 15-cm VAS with anchors "No Disease" and "Very Severe Disease"
No measurements were reported for this outcome.
Patient-reported outcome that represents the participant's assessment of his or her current overall health (Question: How was your overall health in the last week?) rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage.
| score on a scale | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in Patient Global Assessment of Disease Activity (PtGA) | 3.4 ± 3.3 |
Physician-reported outcome that represents an assessment of the participant's current overall health rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage.
| score on a scale | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in Physician Global Assessment of Disease Activity (MDGA) | 1.7 ± 1.0 |
ACR CRISS calculates the predicted probability of improvement in a 2-step process. Four possible outcomes in Step 1 include worsening of FVC % predicted by at least 15%, new decline of left ventricular ejection fraction to 45% or less attributable to scleroderma and needing treatment, new onset pulmonary arterial hypertension attributable to scleroderma and scleroderma renal crisis. If any one of these outcomes develops as a change from baseline, the participant is classified as not improved (score = 0) regardless of changes in other parameters. Step 2 calculates change from baseline in the predicted probability of improvement based on combined changes in the mRSS, FVC % predicted, patient global assessment, physician global assessment, and HAQ-DI. The calculated probability ranges from 0 (not improved) to 1.0 where a higher score indicates improvement.
No measurements were reported for this outcome.
DLCO is the amount of carbon monoxide (CO) that moves from the lungs to the blood
| percentage of carbon monoxide | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Change in Diffusion Capacity (DLCO) % Predicated | 0 ± 5.30 |
Collected over Adverse events were collected from baseline to completion of the post-treatment follow-up visit, approximately 16 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) | 1/4 (25%) | 0/4 (0%) | 3/4 (75%) |
| Event | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| PruritusNervous system disorders | 2/4 |
| RashSkin and subcutaneous tissue disorders | 2/4 |
| VomitingGastrointestinal disorders | 2/4 |
| DiarrheaGastrointestinal disorders | 2/4 |
| FeverInfections and infestations | 1/4 |
| HyponatremiaNervous system disorders | 1/4 |
| HypokalemiaNervous system disorders | 1/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/4 |
| Age, Continuous(years) | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Mean | 58 ± 23.2 |
| Sex: Female, Male(Participants) | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Female | 3 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Ixazomib in Patients With Scleroderma-interstitial Lung Disease (ILD) |
|---|---|
| United States | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2021 to primary completion in Feb 2024, 33 months.
Results were first posted in Apr 2025, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ixazomib