Lenabasum 20 mg for Dermatomyositis

Phase-Based Estimates
2
Effectiveness
3
Safety
University Medical Center Goettingen, Göttingen, Germany
Dermatomyositis
Lenabasum 20 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Dermatomyositis

Study Summary

This study is evaluating whether a drug called lenabasum can improve muscle strength and function in people with dermatomyositis.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Lenabasum 20 mg will improve 1 primary outcome and 9 secondary outcomes in patients with Dermatomyositis. Measurement will happen over the course of Week 28.

Week 28
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score
Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.
Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.
Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)
Subjects who achieve Definition of Improvement (DOI)
Subjects who achieve TIS >= 40 (at least moderate improvement)
Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity
TIS, lenabasum 5 mg BID versus placebo
Week 52
TIS at Visit 10
TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline

Trial Safety

Trial Design

3 Treatment Groups

Placebo
Lenabasum 20 mg
Placebo group

This trial requires 176 total participants across 3 different treatment groups

This trial involves 3 different treatments. Lenabasum 20 Mg is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Lenabasum 20 mg
Drug
Subjects will receive lenabasum 20 mg twice daily
Lenabasum 5 mg
Drug
Subjects will receive lenabasum 5 mg twice daily
Placebo
Drug
Subjects will receive placebo twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ajulemic acid
Not yet FDA approved
Ajulemic acid
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 52 for reporting.

Closest Location

University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
ACR/EULAR criteria (Lundberg et al, 2017)
MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of 150 total possible)
Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14
Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is dermatomyositis?

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A significant portion of dermatomyositis patients presenting in dermatology and rheumatology clinics have at least one psychiatric disorder. Patients with anti-dsDNA antibodies, antibodies to antisynthetase/SSB and rheumatoid factor have a higher prevalence of psychiatric disorders. A history of psychiatric illness in patients with dermatomyositis should raise the possibility of underlying psychiatric disorder and should be pursued in a multidisciplinary setting.

Unverified Answer

How many people get dermatomyositis a year in the United States?

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Although our result is not conclusive, there is evidence that dermatomyositis is common in several U.S. races/ethnicities. This suggests that our results may not be reflective of the population in general. It is important to note that there is no evidence that Blacks or Hispanics have a higher likelihood of getting dermatomyositis than Caucasians or Asians. Further research may reveal interesting results.

Unverified Answer

What are common treatments for dermatomyositis?

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Common treatments are focused on muscle pain prevention by exercise or manual therapy; fatigue relievers such as NSAIDs, analgesics or muscle relaxants; immunosuppressants; and corticosteroids. In more severe cases, immunosuppressive agents, as well as anti-oxidants, antioxidants, and antiallergic agents are used. In some cases, combinations of these are used in managing the disease. There are no treatments that can permanently prevent myositis or the complications of DM.

Unverified Answer

What causes dermatomyositis?

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Genetic predisposition is a likely cause of DM, but other factors, including a history of exposure to certain chemicals or chemical residues or toxins are also possible. DM is a rare autoimmune disease in children of all races and there are differences regarding the disease’s incidence (more frequent among whites than in African Americans) and clinical features between children of different genders, ages, and races. We reviewed the literature and described the clinical presentation of our cases and compared our findings with the findings in previous reports and the data available in the literature.

Unverified Answer

Can dermatomyositis be cured?

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In this review of the treatment of DM, there are only case reports of people who are cured. It should be recognized that most patients with DM do not develop joint pains after treatment, and many have ongoing improvement in symptoms (dysfunctional illness, fatigue). The term "cures" in dermatomyositis is overused and should not be ascribed to treatment.

Unverified Answer

What are the signs of dermatomyositis?

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These symptoms are similar, though not identical, to the signs caused by RAS. As the rash is characteristic of most forms of dermatomyositis, diagnosis can usually be made without biopsy. The presence of erythema multiforme is specific and may indicate a recent or ongoing infection so that biopsy is needed. This is particularly important if the patient is immunosuppressed.

Unverified Answer

What does lenabasum 20 mg usually treat?

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Both difetamide and lenabasum 20 mg were well tolerated in patients with systemic-onset juvenile dermatomyositis. However, lenabasum 20 mg was superior to difetamide with regard to the duration of disease remission and to a lower incidence of serious toxicity. Findings from a recent study of this study demonstrate that lenabasum 20 mg is superior to difetamide in JDM.

Unverified Answer

What is the latest research for dermatomyositis?

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The most recent studies have shown that the autoimmune process is an etiology of the disease, either a genetically determined occurrence (40%), or a primary autoimmune injury. In both cases, the inflammatory process predominates as the initiating event. This process triggers a rapid autoimmune and immunologic reaction in a subgroup of people, with an acceleration in an autoimmune process and eventual transformation into the disease. It is important to distinguish autoimmune myositis from myopathy and polymyositis.

Unverified Answer

How does lenabasum 20 mg work?

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A single 20 mg dose of lenabasum produced significant improvements in most of the clinical parameters and a high proportion of patients had a clinical response.

Unverified Answer

Have there been any new discoveries for treating dermatomyositis?

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Over the past decade we have seen the development of new treatment strategies for many of the currently available drugs. There is still much work to be done to improve their efficacy, which must be done before their use becomes the standard of care.

Unverified Answer

Who should consider clinical trials for dermatomyositis?

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In general, clinical studies are needed for new agents. Specific studies of immunosuppressive agents should be pursued, especially in people with DM whose disease improves after treatment. These are a growing group of patients and research studies should focus on the most important outcomes and most likely to be affected by their use. We believe that clinicians will ultimately have the best approach regarding clinical trials.

Unverified Answer

What is the primary cause of dermatomyositis?

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This survey results provide the first comprehensive look at the primary causes of DM to the clinician. The current survey findings provide evidence to support the hypotheses that DM is more likely to be associated with autoimmune diseases (especially polymyositis and dermatomyositis overlap syndrome) and with genetic defects that regulate the immune system.

Unverified Answer
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