AzTrials
AzTrials

DermatomyositisPhase 3DETERMINENCT03813160

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

A Phase 3 study testing Lenabasum 20 mg and Lenabasum 5 mg in people with Dermatomyositis, run by Corbus Pharmaceuticals Inc. at 54 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatomyositis
What is being tested?
Lenabasum 20 mg and Lenabasum 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
54 sitesin 13 countries
Study dates
17 Dec 2018to 5 Oct 2021
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fulfill at least one of the following criteria for dermatomyositis:
  • Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
  • ACR/EULAR criteria (Lundberg et al, 2017)
  • Disease activity/severity fulfills at least one of the following three criteria:
  • 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)
Show all 10Show fewer
  • MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14
  • Stable doses of immunosuppressive medications for DM as defined by:
  • 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

Who cannot join

  • Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
  • Significant diseases or conditions other than DM that may influence response to the study drug or safety
  • Any of the following values for laboratory tests at Screening:
  • A positive pregnancy test (or at Visit 1)
  • Hemoglobin < 9 g/dL in males and < 8 g/dL in females
  • Neutrophils < 1.0 × 10^9/L
  • Platelets < 75 × 10^9/L
  • Creatinine clearance < 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement

Trial locations and contacts

54 sites in 13 countries.

54 sites in 13 countries

United States23 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Austin Neuromuscular Center

    Austin, Texas, 78756

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Attune Health Center

    Beverly Hills, California, 90211

  • MUSC: Department of Neurology

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • UCLA Division of Rheumatology

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota, Division of Rheumatic and Autoimmune Diseases

    Minneapolis, Minnesota, 55455

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Hospital for Special Surgery

    New York, New York, 10021

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • HonorHealth Neurology

    Phoenix, Arizona, 85018

  • University of Pittsburgh, Division of Rheumatology

    Pittsburgh, Pennsylvania, 15261

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33612

  • Georgetown University

    Washington D.C., District of Columbia, 20001

Other trials in United States

Japan9 sites

  • Gunma University Hospital

    Gunma

  • Hokkaido University Hospital

    Hokkaido

  • Yokohama City University Hospital

    Kanagawa

  • Kyoto University Hospital

    Kyoto

  • Tohoku University Hospital

    Miyagi

  • Osaka University Hospital

    Osaka

  • Keio University Hospital

    Tokyo

  • Nippon Medical School Hospital

    Tokyo

  • Wakayama Medical Hospital

    Wakayama

Other trials in Japan

South Korea4 sites

  • Inha University Hospital

    Incheon

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Hospital

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

Bulgaria3 sites

  • University Hospital "Kaspela" Rheumatology Clinic

    Plovdiv

  • UMHAT "St. Ivan Rilski"

    Sofia

  • UMHAT

    Stara Zagora, 6000

Other trials in Bulgaria

Germany3 sites

  • Charite-Universitatsmedizin

    Berlin

  • University Hospital Erlangen Nuremberg

    Erlangen, D- 91054

  • University Medical Center Goettingen

    Göttingen

Other trials in Germany

Poland3 sites

  • KLIMED

    Bialystok

  • KLIMED

    Łomża, 18-404

  • Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii

    Rzeszów, 35-055

Other trials in Poland

Italy2 sites

  • University Hospital Policlinico-Vittorio Emanuele

    Catania, 95121

  • Fondazione Policlinico Universitario A.Gemelli-IRCCS

    Roma, 00168

Other trials in Italy

Spain2 sites

  • Vall d'Hebron General Hospital

    Barcelona

  • Hospital 12 Octubre

    Madrid

Other trials in Spain

Canada1 site

  • University of British Columbia, Dept. of Dermatology and Skin Science

    Vancouver, British Columbia, V5Z 4E8

Other trials in Canada

Czechia1 site

  • Revmatologicky ustav

    Prague, 12850

Other trials in Czechia

Hungary1 site

  • University of Debrecen

    Debrecen

Other trials in Hungary

Sweden1 site

  • Karolinska University Hospital, Rheumatology Clinic

    Stockholm

Other trials in Sweden

United Kingdom1 site

  • King's College Hospital NHS Foundation Trust

    London

Other trials in United Kingdom

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Read the detailed description

Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

Conditions
Dermatomyositis
Being tested
Lenabasum 20 mg, Lenabasum 5 mg, Placebo
Keywords
dermatomyositis, cannabinoid receptor type 2 agonist, JBT-101, lenabasum
Medical subject headings
Dermatomyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenabasum 20 mgDrug

    Also called JBT-101, anabasum

    oral capsule

  • Lenabasum 5 mgDrug

    Also called JBT-101, anabasum

    oral capsule

  • PlaceboDrug

    oral capsule

Study groups in NCT03813160
Study groupRoleWhat they receive
Lenabasum 20 mgExperimentalSubjects will receive lenabasum 20 mg twice daily
Receives: Drug: Lenabasum 20 mg
Lenabasum 5 mgExperimentalSubjects will receive lenabasum 5 mg twice daily
Receives: Drug: Lenabasum 5 mg
PlaceboPlacebo comparatorSubjects will receive placebo twice daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS)

    TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

    Measured: Week 28

Secondary outcomes (9)

  1. Subjects who achieve Definition of Improvement (DOI)

    Defined as ≥ 3 of 6 core set measures improved by ≥ 20% (relative to Baseline) with no more than 2 core set measures worsening by ≥ 25% (MMT-8 may not decrease by ≥ 25% from baseline)

    Measured: Week 28

  2. Subjects who improve by at least one category on the Investigator Global Assessment (IGA) scale of skin activity

    The IGA is used by the investigator to score overall skin disease on a 0 to 4 scale; higher scores indicate greater skin disease.

    Measured: Week 28

  3. Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score

    CDASI is a validated outcome measure that systematically quantifies cutaneous DM disease activity and damage (Klein et al, 2007; Yassaee et al, 2010) Disease Activity Score is rated using three activity measures. The activity score ranges from 0 to 100. Higher scores indicate greater disease severity.

    Measured: Week 28

  4. Subjects who achieve TIS >= 40 (at least moderate improvement)

    TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

    Measured: Week 28

  5. TIS in subjects receiving immunosuppressive therapies (including corticosteroids) for > 1 year at Baseline

    TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

    Measured: Week 52

  6. Change in Forced vital capacity (FVC) absolute, in all subjects and those with interstitial lung disease (ILD) at Baseline.

    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

    Measured: Week 28

  7. Change in Forced vital capacity (FVC) percent predicted, in all subjects and those with interstitial lung disease (ILD) at Baseline.

    ILD is defined as a history of fibrosis on chest x-ray, a history of ILD on CT of lungs, and/or FVC% predicted <80% at Screening or Visit 1

    Measured: Week 28

  8. TIS at Visit 10

    TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

    Measured: Week 52

  9. TIS, lenabasum 5 mg BID versus placebo

    TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start17 Dec 2018
  3. Primary completion31 Mar 2021
  4. Study completion5 Oct 2021

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03813160
Sponsor's protocol ID
JBT101-DM-002
Acronym
DETERMINE
Status last verified
Aug 2022
First submitted
21 Jan 2019
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kodali N, Diaz D, Dhiman R, Vazquez T, Feng R, Patel J, Dan J, Sprow G, Kleitsch J, Sharma M, Bashir M, Werth VP. Diverse Lenabasum pathway activation in dermatomyositis patients' blood. Sci Rep. 2025 May 18;15(1):17232. doi: 10.1038/s41598-025-92001-z.

    PubMed 40383862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenabasum 20 mg and Lenabasum 5 mg in people with Dermatomyositis, run by Corbus Pharmaceuticals Inc. at 54 sites in 13 countries.

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 10 inclusion and 8 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: finished, as of the sponsor's last update on 16 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 54 sites in United States, Japan, South Korea, Bulgaria, Germany and 8 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of lenabasum 20 mg BID compared to placebo BID as measured by Total Improvement Score (TIS) (time frame: Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03813160, which also lists 1 linked publication.

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 16 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in