DRESS SyndromeEarly Phase 1NCT04988256
Cyclosporine Vs Steroids in DRESS
A Early Phase 1 study testing Cyclosporine and Methylprednisolone and Prednisone in people with DRESS Syndrome and Drug-Induced Hypersensitivity Syndrome, run by University of Southern California at 1 site in United States.
Trial summary
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DRESS Syndrome, Drug-Induced Hypersensitivity Syndrome
- What is being tested?
- Cyclosporine and Methylprednisolone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)
Who cannot join
- Active sepsis
- Active hepatitis B or C
- Active tuberculosis
- Documented allergy to steroids or cyclosporine
- Estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis, in which case they will be included)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.
This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS.
Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis in which case the participants will be included).
Read the detailed description
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids, cyclosporine and to a lesser extent, intravenous immunoglobulin (IVIG). Regarding IVIG, a recent case series suggests no improved benefit in adults. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.
This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS. Hopefully, this study will allow the investigators to better power a full prospective trial in the future.
This is a potentially life-threatening severe cutaneous adverse reaction (SCAR) with significant potential morbidity. Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis in which case the participants will be included).
Participants will be randomized using a randomization protocol at all sites. Primary endpoints will include percentage of participants with complete or near complete resolution of organ involvement as well as erythema resolution at day 7 and day 30.
Secondary endpoints will be:
- fever presence, resolution of facial edema, resolution of pruritus, lymphadenopathy, eosinophil count at days 7 and 30
- days of hospitalization
- mortality at days 7, 30 and 90
- viral reactivation at days 30, 60 and 90
- those with autoimmune development by day 30 and day 90
- 30 day re-admission rate.
- Being tested
- Cyclosporine, Methylprednisolone and Prednisone
- Medical subject headings
- Drug Hypersensitivity Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
Patients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description"
Methylprednisolone and PrednisoneDrug
All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Active comparator | All Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO)
1. If complete resolution, stop cyclosporine and monitor closely for relapse
a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days
i. If down-trending, start oral taper regimen
ii. If not down-trending, switch to steroid arm
2. If >25% improvement and labs are down-trending, start the oral taper regimen.
3. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days
1. If down-trending, start oral taper regimen
2. If not down-trending, switch to steroid arm
4. If no improvement or up-trending labs at 7 days, switch to steroid arm
Oral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days Receives: Drug: Cyclosporine |
| Corticosteroids | Experimental | All Patients start with 500 mg IV Methylprednisolone for 3 days
1. If >25% improvement (must be >25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days
1. If no improvement, switch to cyclosporine arm of treatment
2. If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days
i. If labs are down-trending, start the taper regimen
ii. If labs are not down-trending, switch to cyclosporine arm of the study
c. If >25% improvement, start the taper regimen
Taper Regimen set as:
1. 125 mg IV Methylprednisolone x3 days
2. 1.2 mg/kg PO prednisone x1 week
3. 1 mg/kg PO prednisone x1 week
4. 0.8 mg/kg PO prednisone x1 week
5. 0.6 mg/kg PO prednisone x1 week
6. 0.4 mg/kg PO prednisone x1 week
7. 0.2 mg/kg PO prednisone x1 week
8. 0.1 mg/kg PO prednisone x1 week
9. 0.05 mg/kg PO prednisone x1 week Receives: Drug: Methylprednisolone and Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Measured by the following quantitative metrics:
- Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher
- Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher
- Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher
- Resolution of interstitial pneumonitis on chest x-ray
Measured: Day 7
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Measured by the following quantitative metrics:
- Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher
- Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher
- Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher
- Resolution of interstitial pneumonitis on chest x-ray
Measured: Day 30
Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy
Clinical measurement of erythema
Measured: Day 7
Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy
Clinical measurement of erythema
Measured: Day 30
Secondary outcomes (20)
Percentage of patients with resolution of fever
Less than 38 degrees Celsius for at least 24 hours
Measured: Day 7
Percentage of patients with resolution of fever
Less than 38 degrees Celsius for at least 24 hours
Measured: Day 30
Percentage of patients with resolution of facial edema
Clinical resolution of edema for at least 24 hours
Measured: Day 7
Percentage of patients with resolution of facial edema
Clinical resolution of edema for at least 24 hours
Measured: Day 30
Percentage of patients with resolution of pruritus
Resolution for at least 24 hours
Measured: Day 7
Percentage of patients with resolution of pruritus
Resolution for at least 24 hours
Measured: Day 30
Percentage of patients with resolution of lymphadenopathy
Clinical resolution of lymphadenopathy for at least 24 hours
Measured: Day 7
Percentage of patients with resolution of lymphadenopathy
Clinical resolution of lymphadenopathy for at least 24 hours
Measured: Day 30
Absolute eosinophil proportion compared to peak value
Proportion of absolute eosinophils
Measured: Day 7
Absolute eosinophil proportion compared to peak value
Proportion of absolute eosinophils
Measured: Day 30
Patients with autoimmune disease development
Measured by titers of autoimmune markers (Antinuclear Antibody (ANA), Thyroid Stimulating Hormone (TSH)) compared to baseline
Measured: Day 30
Patients with autoimmune disease development
Measured by titers of autoimmune markers (Antinuclear Antibody (ANA), Thyroid Stimulating Hormone (TSH)) compared to baseline
Measured: Day 90
Total days of hospitalization after initial dermatology consult
Number of days
Measured: 0-120 days
Viral reactivation
Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)
Measured: Day 30
Viral reactivation
Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)
Measured: Day 60
Viral reactivation
Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)
Measured: Day 90
Mortality
Proportion of patient mortality
Measured: Day 7
Mortality
Proportion of patient mortality
Measured: Day 30
Mortality
Proportion of patient mortality
Measured: Day 90
30-day readmission rate
Proportion of patients re-admitted to the hospital within 30 days of discharge
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start27 Sep 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DRESS SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Worswick, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988256
- Sponsor's protocol ID
- HS-20-00118
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS
- ClinicalTrials.gov ID
- NCT04988256
- Acronym / sponsor ID
- HS-20-00118
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.
This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS.
Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis in which case the participants will be included).
Detailed description
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids, cyclosporine and to a lesser extent, intravenous immunoglobulin (IVIG). Regarding IVIG, a recent case series suggests no improved benefit in adults. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.
This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS. Hopefully, this study will allow the investigators to better power a full prospective trial in the future.
This is a potentially life-threatening severe cutaneous adverse reaction (SCAR) with significant potential morbidity. Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis in which case the participants will be included).
Participants will be randomized using a randomization protocol at all sites. Primary endpoints will include percentage of participants with complete or near complete resolution of organ involvement as well as erythema resolution at day 7 and day 30.
Secondary endpoints will be:
- fever presence, resolution of facial edema, resolution of pruritus, lymphadenopathy, eosinophil count at days 7 and 30
- days of hospitalization
- mortality at days 7, 30 and 90
- viral reactivation at days 30, 60 and 90
- those with autoimmune development by day 30 and day 90
- 30 day re-admission rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Active comparator | Drug: CyclosporineAll Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO) 1. If complete resolution, stop cyclosporine and monitor closely for relapse a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days i. If down-trending, start oral taper regimen ii. If not down-trending, switch to steroid arm 2. If >25% improvement and labs are down-trending, start the oral taper regimen. 3. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days 1. If down-trending, start oral taper regimen 2. If not down-trending, switch to steroid arm 4. If no improvement or up-trending labs at 7 days, switch to steroid arm Oral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days |
| Corticosteroids | Experimental | Drug: Methylprednisolone and PrednisoneAll Patients start with 500 mg IV Methylprednisolone for 3 days 1. If >25% improvement (must be >25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days 1. If no improvement, switch to cyclosporine arm of treatment 2. If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days i. If labs are down-trending, start the taper regimen ii. If labs are not down-trending, switch to cyclosporine arm of the study c. If >25% improvement, start the taper regimen Taper Regimen set as: 1. 125 mg IV Methylprednisolone x3 days 2. 1.2 mg/kg PO prednisone x1 week 3. 1 mg/kg PO prednisone x1 week 4. 0.8 mg/kg PO prednisone x1 week 5. 0.6 mg/kg PO prednisone x1 week 6. 0.4 mg/kg PO prednisone x1 week 7. 0.2 mg/kg PO prednisone x1 week 8. 0.1 mg/kg PO prednisone x1 week 9. 0.05 mg/kg PO prednisone x1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)
Key exclusion criteria (5 listed)
- Active sepsis
- Active hepatitis B or C
- Active tuberculosis
- Documented allergy to steroids or cyclosporine
- Estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis, in which case they will be included)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclosporinePatients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description" | Drug | Cyclosporine |
| Methylprednisolone and PrednisoneAll patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper. | Drug | Corticosteroids |
Primary outcome
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Time frame: Day 7
Measured by the following quantitative metrics: * Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher * Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher * Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher * Resolution of interstitial pneumonitis on chest x-ray
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Time frame: Day 30
Measured by the following quantitative metrics: * Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher * Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher * Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher * Resolution of interstitial pneumonitis on chest x-ray
Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy
Time frame: Day 7
Clinical measurement of erythema
Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy
Time frame: Day 30
Clinical measurement of erythema
20 secondary outcomes
Percentage of patients with resolution of fever
Time frame: Day 7
Percentage of patients with resolution of fever
Time frame: Day 30
Percentage of patients with resolution of facial edema
Time frame: Day 7
Percentage of patients with resolution of facial edema
Time frame: Day 30
Percentage of patients with resolution of pruritus
Time frame: Day 7
Percentage of patients with resolution of pruritus
Time frame: Day 30
Percentage of patients with resolution of lymphadenopathy
Time frame: Day 7
Percentage of patients with resolution of lymphadenopathy
Time frame: Day 30
Absolute eosinophil proportion compared to peak value
Time frame: Day 7
Absolute eosinophil proportion compared to peak value
Time frame: Day 30
Patients with autoimmune disease development
Time frame: Day 30
Patients with autoimmune disease development
Time frame: Day 90
Total days of hospitalization after initial dermatology consult
Time frame: 0-120 days
Viral reactivation
Time frame: Day 30
Viral reactivation
Time frame: Day 60
Viral reactivation
Time frame: Day 90
Mortality
Time frame: Day 7
Mortality
Time frame: Day 30
Mortality
Time frame: Day 90
30-day readmission rate
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cyclosporine and Methylprednisolone and Prednisone in people with DRESS Syndrome and Drug-Induced Hypersensitivity Syndrome, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.