A Phase 4 interventional study of maraviroc (Selzentry, Celsentri) in Myositis, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Chinese University of Hong Kong · Phase 4, Interventional, and Treatment
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).
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.
215 studies on the registry are indexed under Myositis; 100 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 141 interventional studies indexed under Myositis.
Browse Myositis studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: maraviroc (Selzentry, Celsentri)
The first study of repurposing Maraviroc for the treatment of myositis
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.
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Maraviroc
Chinese University of Hong Kong →