Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis

NCT05488327 | Unknown

• 1 other identifier: DLH88086
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.

Conditions

Dermatomyositis

Keywords

Cutaneous Dermatomyositis, Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Cutaneous Disease Activity Severity Index (CDASI) activity score

  Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome

  24 weeks

Secondary Outcomes (5)

• Cutaneous Disease Activity Severity Index (CDASI) activity score

  12 weeks

• International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures

  12 weeks and 24 weeks

• SF-36

  12 weeks and 24 weeks

• Dermatology Life Quality Index (DLQI)

  12 weeks and 24 weeks

• Adverse event

  24 weeks

Study Arms (1)

Intervention with lenalidomide

EXPERIMENTAL

All subjects will be treated with lenalidomide 5mg/day.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

All subjects will be treated with lenalidomide 5mg/day with a regular follow-up of 24 weeks.

Intervention with lenalidomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant、non-nursing female.
• Age 18 to 75 years at the time of signing informed consent.
• Fulfilling 2017 ACR/EULAR IIMs classification criteria for DM or ADM.
• Disease activity with skin damage (CDASI ≥12) despite treatment with corticosteroids, immunosuppressive agents or biologics for more than 3 months.
• Written informed consent obtained before taking part in the study.

You may not qualify if:

• Pregnant women or breastfeeding mothers, Male and female patients with recent fertility requirements.
• Skin and mucosal lesions should exclude erythema multiforme, syphilis, Sweet disease, Stevens-Johnson syndrome, acne vulgaris, herpes simplex infection, periodic granulocytopenia, and acquired immunodeficiency.
• Severe Concomitant disease: including heart failure (≥level Ⅲ, NYHA), respiratory failure, myelosuppression (WBC\<3.0×109/L or N\<1.5×109/L, HGB≤85g/L, PLT\<100×109/L), peripheral neuropathy.
• Acute severe infections such as sepsis and cellulitis, active hepatitis B or C virus infection, active tuberculosis, and history of a positive test for, or any clinical suspicion of, human immunodeficiency virus (HIV).
• Patients with risk factors for myocardial infarction (including a history of thrombosis), hypercoagulability, or with history of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
• Patients with allergies or contraindications to lenalidomide or thalidomide.
• Uncontrolled or rapidly progressive myositis or interstitial lung disease at the discretion of the investigator which is likely to warrant escalation in therapy beyond permitted background medications.
• Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including HIV.
• History of recurrent herpes zoster, disseminated (multi-dermatomal) herpes zoster, disseminated herpes simplex or ophthalmic zoster. Herpes zoster lesions within 90 days prior to screening.
• Primary or secondary immunodeficiency.
• Current uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, which, in the opinion of the investigator, might place the patient at unacceptable risk for participation in this study.
• History of alcohol, drug, or chemical abuse within one year prior to signing the informed consent form.
• Major surgery within 8 weeks prior to Screening or planned major surgery at any time during participation in the study.
• Immunization with a live/attenuated vaccine within 4 weeks prior to Screening.
• History of malignant tumor within 5 years prior to screening (stable disease for more than 6 months after completion of tumor treatment program can be enrolled).

Sponsors & Collaborators

• Jiangxi Provincial People's Hopital: lead

Study Sites (1)

Department of Rheumatology and Clinical Immunology, Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lihua Duan, MD

  Jiangxi Provincial People's Hopital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihua Duan, MD

CONTACT

0791-86895639; lh-duan@163.com

Jiao Luo, MD

CONTACT

0791-86895639; luojiao02@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 4, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)