Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies

NCT07668505 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025.800
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Myositis

Keywords

myositis; anti-inflammation; CCR5; Maraviroc

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• Muscle histological features

  From enrollment to the end of treatment at 12 weeks

• Muscle oedema (inflammation) and fatty infiltration (damage)

  From enrollment to the end of treatment at 12 weeks

• Levels of CCR5 and CCL5 expressions

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Maraviroc group

EXPERIMENTAL

Drug: maraviroc (Selzentry, Celsentri)

Interventions

maraviroc (Selzentry, Celsentri) DRUG

The first study of repurposing Maraviroc for the treatment of myositis

Maraviroc group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• Pregnancy or lactation,
• Malignancy
• Functional class 4
• Contraindication to Maraviroc.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Myositis

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Huating Wang, Ph.d

CONTACT

(852) 3763 6047; huating.wang2011@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

HK (1)