MyositisPhase 4NCT07668505
Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
A Phase 4 study testing maraviroc (Selzentry, Celsentri) in people with Myositis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies. It will also learn about how the drug affects muscle inflammation and function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myositis
- What is being tested?
- maraviroc (Selzentry, Celsentri)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2026to 31 Aug 2029
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 to <80 years of age
- Myositis disease onset >18 years
- Fulfillment of 2017 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) IIM classification criteria
- Active myositis defined as Manual Muscle Testing 8 (MMT8) score <142 with at least two other abnormal International Myositis Assessment \& Clinical Studies Group (IMACS) core set measures (Visual Analogue Scale (VAS) of patient global activity ≥2 cm, physician's global disease activity ≥2 cm, at least one muscle enzyme >1.5 times upper limit of normal, Health ssessment Questionnaire(HAQ) ≥0.25), despite 2 additional immunosuppressive treatments on top of glucocorticoids.
Who cannot join
- Pregnancy or lactation,
- Malignancy
- Functional class 4
- Contraindication to Maraviroc.
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 Novel Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies. It will also learn about how the drug affects muscle inflammation and function. The main questions it aims to answer are: Does Maraviroc reduce inflammation in the muscles? Does Maraviroc improve patients' muscle function and overall clinical symptoms? This is an open-label study, meaning researchers will give Maraviroc to all participants (there is no placebo) to see if the drug works to treat refractory myositis. Participants will: Take a 300mg Maraviroc tablet every day for 12 weeks. Undergo exams and tests with their doctors to check their muscle function, symptom improvement, and specific health markers (like enzyme levels).
Read the detailed description
Objective:
This is an open-label clinical trial using Maraviroc for the treatment of refractory idiopathic inflammatory myopathy (myositis).
The hypothesis to be tested:
Findings from our pilot study demonstrate that Maraviroc has an anti-inflammatory effect in both dystrophic and aging muscle. We thus hypothesize that Maraviroc can be used for treating patients with refractory myositis by repressing the inflammation in muscles.
Design and subjects:
10 patients with refractory myositis who do not respond well to traditional therapy will be recruited for the clinical trial. The patients will receive Maraviroc tablets 300mg daily for 12 weeks of treatment, and their myositis-related manifestations will be examined to evaluate the treatment effect.
Main outcome measures:
The primary outcome for the trial will be the IMACS definition of minimal clinical improvement (DOI). IMACS defined the 2016 ACR/EULAR criteria for clinical response based on 6 core set measurements (CSMs), including physician global activity, patient global activity, MMT-8, health assessment questionnaire, enzymes, and extramuscular activity score. The total improvement score is the sum of all 6 improvement scores of each core set measure.
Expected results:
The Maraviroc treatment is expected to reduce inflammation in muscles and improve muscle function in patients.
- Conditions
- Myositis
- Being tested
- maraviroc (Selzentry, Celsentri)
- Keywords
- myositis, anti-inflammation, CCR5, Maraviroc
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maraviroc (Selzentry, Celsentri)Drug
The first study of repurposing Maraviroc for the treatment of myositis
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc group | Experimental | Not described Receives: Drug: maraviroc (Selzentry, Celsentri) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMACS definition of minimal clinical improvement (DOI)
IMACS defined the 2016 ACR/EULAR criteria for clinical response based on 6 core set measurements (CSMs), including physician global activity, patient global activity, MMT-8, health assessment questionnaire, enzymes, extramuscular activity score. Minimal clinical improvement is defined by 3 of any of the 6 CSMs improved by ≥ 20%, with no more than 2 CSMs worsening by ≥ 25% (worsening measure cannot include the MMT-8). The response rate will be calculated by the Total Improvement Score (TIS) using the 2016 ACR/EULAR myositis response criteria.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Muscle histological features
Changes in muscle histological features analyzed on conchotome muscle biopsies, which will be performed at baseline and 12 weeks. Biopsies will be sectioned to examine the levels of perifascicular atrophy, inflammation, distribution and types of inflammatory cells (e.g., CD163, CD68 for monocytes/macrophages; CD4, CD8 for T cells; CD20 for B cells), degenerating/regenerating fibers, and fibrosis. We expect to observe a decreased level of inflammation, fibrosis, and fiber degeneration.
Measured: From enrollment to the end of treatment at 12 weeks
Muscle oedema (inflammation) and fatty infiltration (damage)
Changes in muscle oedema (inflammation) and fatty infiltration (damage) detected by MRI of muscles will be obtained at baseline and 12 weeks. MRI images will be reviewed by a radiologist blinded to the clinical information of the patient.
Measured: From enrollment to the end of treatment at 12 weeks
Levels of CCR5 and CCL5 expressions
Changes in the expression levels of CCR5 and CCL5 will be examined
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huating Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668505
- Sponsor's protocol ID
- 2025.800
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
- ClinicalTrials.gov ID
- NCT07668505
- Acronym / sponsor ID
- 2025.800
- Conditions
- Myositis
- Keywords
- myositis, anti-inflammation, CCR5, Maraviroc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 25 Jun 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.
The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies. It will also learn about how the drug affects muscle inflammation and function. The main questions it aims to answer are: Does Maraviroc reduce inflammation in the muscles? Does Maraviroc improve patients' muscle function and overall clinical symptoms? This is an open-label study, meaning researchers will give Maraviroc to all participants (there is no placebo) to see if the drug works to treat refractory myositis. Participants will: Take a 300mg Maraviroc tablet every day for 12 weeks. Undergo exams and tests with their doctors to check their muscle function, symptom improvement, and specific health markers (like enzyme levels).
Detailed description
Objective:
This is an open-label clinical trial using Maraviroc for the treatment of refractory idiopathic inflammatory myopathy (myositis).
The hypothesis to be tested:
Findings from our pilot study demonstrate that Maraviroc has an anti-inflammatory effect in both dystrophic and aging muscle. We thus hypothesize that Maraviroc can be used for treating patients with refractory myositis by repressing the inflammation in muscles.
Design and subjects:
10 patients with refractory myositis who do not respond well to traditional therapy will be recruited for the clinical trial. The patients will receive Maraviroc tablets 300mg daily for 12 weeks of treatment, and their myositis-related manifestations will be examined to evaluate the treatment effect.
Main outcome measures:
The primary outcome for the trial will be the IMACS definition of minimal clinical improvement (DOI). IMACS defined the 2016 ACR/EULAR criteria for clinical response based on 6 core set measurements (CSMs), including physician global activity, patient global activity, MMT-8, health assessment questionnaire, enzymes, and extramuscular activity score. The total improvement score is the sum of all 6 improvement scores of each core set measure.
Expected results:
The Maraviroc treatment is expected to reduce inflammation in muscles and improve muscle function in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maraviroc group | Experimental | Drug: maraviroc (Selzentry, Celsentri) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 to <80 years of age
- Myositis disease onset >18 years
- Fulfillment of 2017 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) IIM classification criteria
- Active myositis defined as Manual Muscle Testing 8 (MMT8) score <142 with at least two other abnormal International Myositis Assessment \& Clinical Studies Group (IMACS) core set measures (Visual Analogue Scale (VAS) of patient global activity ≥2 cm, physician's global disease activity ≥2 cm, at least one muscle enzyme >1.5 times upper limit of normal, Health ssessment Questionnaire(HAQ) ≥0.25), despite 2 additional immunosuppressive treatments on top of glucocorticoids.
Key exclusion criteria (4 listed)
- Pregnancy or lactation,
- Malignancy
- Functional class 4
- Contraindication to Maraviroc.
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 |
|---|---|---|
| maraviroc (Selzentry, Celsentri)The first study of repurposing Maraviroc for the treatment of myositis | Drug | Maraviroc group |
Primary outcome
IMACS definition of minimal clinical improvement (DOI)
Time frame: From enrollment to the end of treatment at 12 weeks
IMACS defined the 2016 ACR/EULAR criteria for clinical response based on 6 core set measurements (CSMs), including physician global activity, patient global activity, MMT-8, health assessment questionnaire, enzymes, extramuscular activity score. Minimal clinical improvement is defined by 3 of any of the 6 CSMs improved by ≥ 20%, with no more than 2 CSMs worsening by ≥ 25% (worsening measure cannot include the MMT-8). The response rate will be calculated by the Total Improvement Score (TIS) using the 2016 ACR/EULAR myositis response criteria.
3 secondary outcomes
Muscle histological features
Time frame: From enrollment to the end of treatment at 12 weeks
Muscle oedema (inflammation) and fatty infiltration (damage)
Time frame: From enrollment to the end of treatment at 12 weeks
Levels of CCR5 and CCL5 expressions
Time frame: From enrollment to the end of treatment at 12 weeks
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 Jun 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing maraviroc (Selzentry, Celsentri) in people with Myositis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 4 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 30 Jun 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 Hong Kong. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Huating Wang, Ph.d ((852) 3763 6047, huating.wang2011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMACS definition of minimal clinical improvement (DOI) (time frame: From enrollment to the end of treatment at 12 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 30 Jun 2026.