DermatomyositisNCT05488327
Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis
A study testing Lenalidomide in people with Dermatomyositis, run by Jiangxi Provincial People's Hopital at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Sep 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Clinical Immunology, Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330000
About this study
Official title: Safety and Efficacy of Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis
The goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.
Read the detailed description
Dermatomyositis (DM) are systemic immune-mediated inflammatory diseases which commonly affected the skin and musculoskeletal system. The cutaneous manifestations of DM are the most important aspect of this disease. Treatment of these cutaneous manifestations is challenging and currently no universally effective drugs exists. Lenalidomide, a second-generation derivative of thalidomide, has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Reports on refractory cutaneous manifestations of systemic lupus erythematosus have been mostly performed. The clinical trials of lenalidomide for cutaneous DM are lacking. This is a single-centre, prospective, open-label, single-arm study with Lenalidomide 5mg/day added to the background treatment of GCs and immunosuppressants in DM to evaluate the efficacy and safety of lenalidomide in the treatment of cutaneous DM.
- Conditions
- Dermatomyositis
- Being tested
- Lenalidomide
- Keywords
- Cutaneous Dermatomyositis, Lenalidomide
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
All subjects will be treated with lenalidomide 5mg/day with a regular follow-up of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with lenalidomide | Experimental | All subjects will be treated with lenalidomide 5mg/day. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (5)
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
Measured: 12 weeks
International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Change in International Myositis Assessment \& Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Measured: 12 weeks and 24 weeks
SF-36
Change in SF-36
Measured: 12 weeks and 24 weeks
Dermatology Life Quality Index (DLQI)
Change in Dermatology Life Quality Index (DLQI)
Measured: 12 weeks and 24 weeks
Adverse event
Adverse event monitoring
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 posted4 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial People's Hopital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lihua Duan, Jiangxi Provincial People's Hopital
- Investigators
- Lihua Duan, MD, Principal investigator, Jiangxi Provincial People's Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488327
- Sponsor's protocol ID
- DLH88086
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis
- ClinicalTrials.gov ID
- NCT05488327
- Acronym / sponsor ID
- DLH88086
- Conditions
- Dermatomyositis
- Keywords
- Cutaneous Dermatomyositis, Lenalidomide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jiangxi Provincial People's HopitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 4 Aug 2022 (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 study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.
Detailed description
Dermatomyositis (DM) are systemic immune-mediated inflammatory diseases which commonly affected the skin and musculoskeletal system. The cutaneous manifestations of DM are the most important aspect of this disease. Treatment of these cutaneous manifestations is challenging and currently no universally effective drugs exists. Lenalidomide, a second-generation derivative of thalidomide, has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Reports on refractory cutaneous manifestations of systemic lupus erythematosus have been mostly performed. The clinical trials of lenalidomide for cutaneous DM are lacking. This is a single-centre, prospective, open-label, single-arm study with Lenalidomide 5mg/day added to the background treatment of GCs and immunosuppressants in DM to evaluate the efficacy and safety of lenalidomide in the treatment of cutaneous DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with lenalidomide | Experimental | Drug: LenalidomideAll subjects will be treated with lenalidomide 5mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| LenalidomideAll subjects will be treated with lenalidomide 5mg/day with a regular follow-up of 24 weeks. | Drug | Intervention with lenalidomide |
Primary outcome
Cutaneous Disease Activity Severity Index (CDASI) activity score
Time frame: 24 weeks
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
5 secondary outcomes
Cutaneous Disease Activity Severity Index (CDASI) activity score
Time frame: 12 weeks
International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Time frame: 12 weeks and 24 weeks
SF-36
Time frame: 12 weeks and 24 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks and 24 weeks
Adverse event
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lihua Duan, MD principal investigator
Jiangxi Provincial People's Hopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenalidomide in people with Dermatomyositis, run by Jiangxi Provincial People's Hopital at 1 site in China.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lihua Duan, MD (0791-86895639, lh-duan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Disease Activity Severity Index (CDASI) activity score (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 4 Aug 2022.