Eosinophilic FasciitisPhase 1NCT04305678
Mepolizumab for Eosinophilic Fasciitis
A Phase 1 study testing Mepolizumab in people with Eosinophilic Fasciitis, run by Mayo Clinic.
Trial summary
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Fasciitis
- What is being tested?
- Mepolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to 15 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male and female patients 18 years or older.
- History and physical examination consistent with EF
- Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
- Documented peripheral eosinophilia (≥500 microliter)
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Who cannot join
- Eosinophilic fascitis disease duration > 5 years
- Known history of adverse reaction to mepolizumab (Nucala)
- Pregnant females
- Females actively trying to conceive
- Vulnerable study population
- Asthma requiring inhaled cortiosteroids
About this study
Official title: Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
Read the detailed description
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.
- Conditions
- Eosinophilic Fasciitis
- Being tested
- Mepolizumab
- Keywords
- Mepolizumab
- Medical subject headings
- Eosinophilic Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Also called Nucala
Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients with a biopsy proven diagnosis of eosinophilic fasciitis Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rodnan Skin Score (mRSS)
Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.
Measured: 24 weeks
Secondary outcomes (7)
Localized Scleroderma Skin Severity Index (mLoSSI) score
Mean change before and after treatment. mLoSSI score quantifies disease activity.
Measured: 24 weeks
Localized Scleroderma Damage Index (LoSDI) score.
Mean change before and after treatment. LoSDI score quantifies disease damage.
Measured: 24 weeks
Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
Measured: 24 weeks
Physician's Global Assessment of Disease Activity (PhysGA-A)
Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.
Measured: 24 weeks
Physician's Global Assessment of Disease Damage (PhysGA-D)
Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.
Measured: 24 weeks.
Dermatology Quality of Life Index (DLQI)
Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
Measured: 24 weeks.
Patient Global Assessment of Disease Severity (PtGA-S)
Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by "not severe" at 0 and "very severe" at 100.
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study startFeb 2023 (estimated)
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Why it stopped: Funding lost from Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic FasciitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mepolizumab for the treatment of eosinophilic faciitis.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Jason Sluzevich MD, Mayo Clinic
- Investigators
- Jason C Sluzevich, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305678
- Sponsor's protocol ID
- 19-011851
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2020
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
- ClinicalTrials.gov ID
- NCT04305678
- Acronym / sponsor ID
- 19-011851
- Conditions
- Eosinophilic Fasciitis
- Keywords
- Mepolizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding lost from Sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2023 (estimated)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 12 Mar 2020 (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.
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
Detailed description
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mepolizumab for the treatment of eosinophilic faciitis.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: MepolizumabPatients with a biopsy proven diagnosis of eosinophilic fasciitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 18 years or older.
- History and physical examination consistent with EF
- Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
- Documented peripheral eosinophilia (≥500 microliter)
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Key exclusion criteria (6 listed)
- Eosinophilic fascitis disease duration > 5 years
- Known history of adverse reaction to mepolizumab (Nucala)
- Pregnant females
- Females actively trying to conceive
- Vulnerable study population
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 |
|---|---|---|
| MepolizumabAlso: NucalaMepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks | Drug | Single Arm |
Primary outcome
Modified Rodnan Skin Score (mRSS)
Time frame: 24 weeks
Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.
7 secondary outcomes
Localized Scleroderma Skin Severity Index (mLoSSI) score
Time frame: 24 weeks
Localized Scleroderma Damage Index (LoSDI) score.
Time frame: 24 weeks
Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Time frame: 24 weeks
Physician's Global Assessment of Disease Activity (PhysGA-A)
Time frame: 24 weeks
Physician's Global Assessment of Disease Damage (PhysGA-D)
Time frame: 24 weeks.
Dermatology Quality of Life Index (DLQI)
Time frame: 24 weeks.
Patient Global Assessment of Disease Severity (PtGA-S)
Time frame: 24 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Fasciitis
RecruitingObservational study
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
Eosinophilic Fasciitis
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. This study is not recruiting at the moment.
Jason C Sluzevich, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mepolizumab in people with Eosinophilic Fasciitis, run by Mayo Clinic.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Modified Rodnan Skin Score (mRSS) (time frame: 24 weeks). 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 20 Nov 2024.