Systemic Sclerosis (SSc)Phase 2IMPACT-SScNCT07734012
Mycophenolate After Stem Cell Transplant for Systemic Sclerosis
A Phase 2 study testing Mycophenolate Mofetil 1000 mg twice daily in people with Systemic Sclerosis (SSc), run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible . We are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Mycophenolate Mofetil 1000 mg twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 2
- 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
- Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.
Who cannot join
- Exclusion criteria are focused on patient safety, namely inability to receive treatment with
- MMF due to contraindications as determine at time of randomization (day 90 / clinic visit #3) including:
- Renal insufficiency (eGFR <25 mL/minute/1.73m2) or
- Neutropenia (ANC <1.0 x 103/mcL) or
- Thrombocytopenia (platelet count <50 000/mcL)
- Previously documented intolerance.
- Pregnant or breastfeeding - Women of childbearing potential who are not willing to use a highly effective method of contraception for the duration of study participation will be excluded
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: Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial
A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .
We are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse.
Read the detailed description
This study is performed determine the feasibility of a larger pragmatic RCT to evaluate the effectiveness of post- Autologous Hemopoietic Stem Cell Transplant (AHSCT) maintenance therapy with mycophenolate mofetil (MMF) in the prevention of Systemic sclerosis (SSc) relapse.
The study will include 6 participants who will be randomized at 1:1 ratio to treatment (MMF) or control arm (no treatment) for 6 months.
The participants will have 6 visits in total : An initial clinic visit will occur prior to stem cell collection. Post-AHSCT, in-person follow-up visits are scheduled on days 30, 90, 180, 270, and 300, with windows of +/- 1 week for days 30 and 90 and +/- 2 weeks for days 180, 270 and 300.
These visits will be coordinated at an established multidisciplinary (Rheumatology + Cell Therapy) clinic that are part of the patient's clinical care. At each visit, the participants will be asked to complete health questionnaires and laboratory tests will be performed as part of the standard of care of AHSCT recipients.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Mycophenolate Mofetil 1000 mg twice daily
- Keywords
- Systemic sclerosis, Stem cell transplant, Mycophenolate mofetil
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil 1000 mg twice dailyDrug
MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT and continued for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil (MMF) | Experimental | MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT. This proposed MMF regimen is used in the management of rheumatic diseases and described in current literature and clinical guidelines. Duration of 6 months Receives: Drug: Mycophenolate Mofetil 1000 mg twice daily |
| Control arm | No intervention | No scleroderma prophylaxis (current standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility:
The number of participants enrolled at a single center over 18 months.
Measured: 18 months
Efficacy :
-Proportion of patients showing an increase in mRSS of >7 between timepoints .
Measured: At day 0,90,180 and 270
Safety : AEs/SAEs
The proportion of patients experiencing a serious AE OR an AE greater that grade 2 (see below) OR an AE requiring discontinuation of the study drug in a participant who has received at least one dose of the study intervention
Measured: Day 90 (treatment start) , Day 180, day 270
Efficacy:
-Proportion of patients requiring initiation of immunosuppressive therapy for progressive SSc manifestations as determined by their treating physicians.
Measured: At day 0,90,180 and 270
Secondary outcomes (8)
Feasibility: Consent rate:
Proportion of eligible patients who provide consent .
Measured: Both prior to AHSCT (clinic visit #1) and at day 90 (clinic visit #3) prior to randomization.
Feasibility: Retention rate: Proportion of participants retained
Proportion of participants retained
Measured: Day 270 (clinic visit #5)
Feasibility: Study completion rate:
Proportion of participants who completed proposed clinical outcomes at all pre determined time points
Measured: Day 270
Feasibility: Adherence rate:
Adherence to study drug measured by proportion of prophylaxis doses received measured by pill counting at follow-up visits.
Measured: Day 180 and Day 270
Clinical outcomes:
Proportion of patients showing a change between timepoints in Modified Rodnan Skin Score (mRSS): Total score range 0 to 51. Higher scores indicate greater skin thickening and more severe skin involvement .
Measured: day 0, 90, 180 and 270
Auto-antibody testing (clinical)
Proportion of patients with a change in auto-antibody testing
Measured: Prior to AHSCT and Day 180 (visit# 4)
Clinical outcome:
Proportion of patients showing a change in Scleroderma Health Assessment Questionnaire (SHAQ) Disability Index between timepoints.
Score range: 0 to 3. Higher scores indicate greater functional disability and worse health status.
Measured: day 0,90,180 and 270
Clinical outcome:
Proportion of patients showing a change in global score between timepoints Patient and physician global score: Visual analog scale (0 to 10)
Measured: Day 0,90,180 and 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consenting participants with SSc treated with AHSCT will receive (in 1:1 ratio) either: * MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT or * No immunoprophylaxis (current standard of care).
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.
- Responsible party
- Sponsor
- Investigators
- Nancy Maltez, Dr, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734012
- Sponsor's protocol ID
- 20260406-01H
- Acronym
- IMPACT-SSc
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07734012
- Acronym / sponsor ID
- IMPACT-SSc / 20260406-01H
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- Systemic sclerosis, Stem cell transplant, Mycophenolate mofetil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Jul 2026 (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.
A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .
We are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse.
Detailed description
This study is performed determine the feasibility of a larger pragmatic RCT to evaluate the effectiveness of post- Autologous Hemopoietic Stem Cell Transplant (AHSCT) maintenance therapy with mycophenolate mofetil (MMF) in the prevention of Systemic sclerosis (SSc) relapse.
The study will include 6 participants who will be randomized at 1:1 ratio to treatment (MMF) or control arm (no treatment) for 6 months.
The participants will have 6 visits in total : An initial clinic visit will occur prior to stem cell collection. Post-AHSCT, in-person follow-up visits are scheduled on days 30, 90, 180, 270, and 300, with windows of +/- 1 week for days 30 and 90 and +/- 2 weeks for days 180, 270 and 300.
These visits will be coordinated at an established multidisciplinary (Rheumatology + Cell Therapy) clinic that are part of the patient's clinical care. At each visit, the participants will be asked to complete health questionnaires and laboratory tests will be performed as part of the standard of care of AHSCT recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consenting participants with SSc treated with AHSCT will receive (in 1:1 ratio) either: * MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT or * No immunoprophylaxis (current standard of care).
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil (MMF) | Experimental | Drug: Mycophenolate Mofetil 1000 mg twice dailyMMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT. This proposed MMF regimen is used in the management of rheumatic diseases and described in current literature and clinical guidelines. Duration of 6 months |
| Control arm | No intervention | –No scleroderma prophylaxis (current standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.
Key exclusion criteria (7 listed)
- Exclusion criteria are focused on patient safety, namely inability to receive treatment with
- MMF due to contraindications as determine at time of randomization (day 90 / clinic visit #3) including:
- Renal insufficiency (eGFR <25 mL/minute/1.73m2) or
- Neutropenia (ANC <1.0 x 103/mcL) or
- Thrombocytopenia (platelet count <50 000/mcL)
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 |
|---|---|---|
| Mycophenolate Mofetil 1000 mg twice dailyMMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT and continued for 6 months. | Drug | Mycophenolate mofetil (MMF) |
Primary outcome
Feasibility:
Time frame: 18 months
The number of participants enrolled at a single center over 18 months.
Efficacy :
Time frame: At day 0,90,180 and 270
-Proportion of patients showing an increase in mRSS of >7 between timepoints .
Safety : AEs/SAEs
Time frame: Day 90 (treatment start) , Day 180, day 270
The proportion of patients experiencing a serious AE OR an AE greater that grade 2 (see below) OR an AE requiring discontinuation of the study drug in a participant who has received at least one dose of the study intervention
Efficacy:
Time frame: At day 0,90,180 and 270
-Proportion of patients requiring initiation of immunosuppressive therapy for progressive SSc manifestations as determined by their treating physicians.
8 secondary outcomes
Feasibility: Consent rate:
Time frame: Both prior to AHSCT (clinic visit #1) and at day 90 (clinic visit #3) prior to randomization.
Feasibility: Retention rate: Proportion of participants retained
Time frame: Day 270 (clinic visit #5)
Feasibility: Study completion rate:
Time frame: Day 270
Feasibility: Adherence rate:
Time frame: Day 180 and Day 270
Clinical outcomes:
Time frame: day 0, 90, 180 and 270
Auto-antibody testing (clinical)
Time frame: Prior to AHSCT and Day 180 (visit# 4)
Clinical outcome:
Time frame: day 0,90,180 and 270
Clinical outcome:
Time frame: Day 0,90,180 and 270
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 19 Oct 2026.
- 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.
Nancy Maltez, Dr principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycophenolate Mofetil 1000 mg twice daily in people with Systemic Sclerosis (SSc), run by Ottawa Hospital Research Institute at 1 site in Canada.
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 7 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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 Canada. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Clinical Research Assistant (613 738 8400 ext. 81630, nasaidi@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: (time frame: 18 months). 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 19 Oct 2026.