Mother and Daughter Hugging

Corbus Pharmaceuticals is now recruiting dermatomysitis patients for an exciting phase 3 clinical trial for lenabasum. The trial, known as DETERMINE, is designed to evaluate the efficacy and safety of lenabasum for the treatment of dermatomyositis.

Earlier trials of lenabasum yielded very positive results, and we are hopeful that these trials could lead to an effective treatment for those with active dermatomyositis. The trial is recruiting 150 adult patients at sites around the world. This study is a double-blinded placebo-controlled one-year study with dermatomyositis patients who have active muscle and/or skin disease.

Here are some of the inclusion criteria*:

  • Diagnosis of dermatomyositis with active skin, muscle, or other organ involvement
  • 18 years of age or older at the time informed consent is signed
  • On stable doses of DM medications, including immunosuppressives

*There are additional criteria that must be met to participate in this study.

If you are interested in participating in this study click here.

About the trial

The DETERMINE phase 3 study will test efficacy and safety of lenabasum in approximately 150 adults with dermatomyositis. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day. The drug is taken orally.

The primary efficacy outcome at week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints, including Physician Global Assessment of Disease Activity, Physician Global Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing, and muscle enzymes. Evaluation of key organ involvement, including muscle, skin, and lungs, will be included in secondary efficacy outcomes. Change from baseline in the Cutaneous Dermatomyositis Activity and Severity index (CDASI) activity score will be a secondary efficacy outcome.

About the drug

Lenabasum has been granted Orphan Drug Designation for the treatment of dermatomyositis and in both the US and the EU. It is a small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) to resolve inflammation and speed bacterial clearance without immunosuppression.

Lenabasum is also believed to limit tissue fibrosis (scarring). Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. Lenabasum has demonstrated promising activity in animal models of skin and lung inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is also active in animal models of lung infection and inflammation in cystic fibrosis and joint inflammation and scarring in rheumatoid arthritis.

Lenabasum is not marijuana, and it does not have the psychoactive properties of cannabis.

If you are interested in participating in this study click here.

5 comments on “Lenabasum in dermatomyositis clinical trial”

  1. 1
    Linda Kobert on December 19, 2018

    For those who might have had trouble connecting with the company about this trial, here is a statement from Corbus Pharmaceuticals: “We are so sorry for the delayed response to some of your inquires. We received a huge influx of emails and calls since Monday but as of this morning have been in touch with everyone who has reached out to the company. We are working on publishing our clinicaltrials.gov page in the coming months. The http://www.ClinicalTrials.gov page will have more information regarding the study, including our participating research centers and eligibility. This would allow you to potentially find a participating research center near you, which you could then contact to find out if you might be eligible to participate. Alternatively, your treating physician may also contact one of our participating research centers on your behalf, once the information is posted. Anyone looking for additional information may email us at DMpatients@corbuspharma.com. “

  2. 2
    Noberto Rodriguez on July 31, 2019

    Hi my name is Noberto Rodriguez I am from Austin Tx I was diagnosed with inclusion body Myositis in 2016. I am on disability and do not work cause of muscle loss and would like to see if there is still a study in Austin Tx Thanks. Noberto

    1. 3
      Linda Kobert on August 2, 2019

      Hello Noberto. The only clinical trial currently available for IBM is the arimoclomol trial. Unfortunately, all 150 available slots for that trial have been filled.

  3. 4
    Megan on September 19, 2019

    What if we have tried immunosuppressants and can’t tolerate them? Are we still excluded from the trial because we’re not on a stable dose of immunosuppressants?

    1. 5
      Linda Kobert on September 20, 2019

      Megan, you should contact the researchers and they will evaluate you to see if you qualify.

Leave a Reply

Your email address will not be published. Required fields are marked *