DermatomyositisPhase 2NCT06887738
Study of NM8074 in Patients with Dermatomyositis (DM)
A Phase 2 study testing NM8074 in people with Dermatomyositis, run by NovelMed Therapeutics.
Trial summary
This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- NM8074
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male and female patients ≥18 years of age at the time of consent.
- A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
- Subjects diagnosed with a probable or definite DM according to 2017 European League Against Rheumatism/American College of Rheumatology (2017 EULAR/ACR).
- Subjects must have proof of vaccination against Neisseria meningitidis (MenACWY and MenB), Streptococcus pneumoniae (PCV13 or PCV15 and PPSV23), and Haemophilus influenzae type b (Hib) taken at least 2 weeks prior to NM8074 administration as per national and local guidelines. If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.
- Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for at least 8 weeks after stopping the investigational drug.
- Male patients and partners of child-bearing potential must agree to use contraceptives, and male patients must agree to refrain from donating sperm for the duration of the study and for at least 8 weeks after stopping the investigational drug.
Who cannot join
- Subjects with drug-induced myositis
- Subjects who have interstitial lung disease requiring the use of supplemental oxygen.
- Use of other investigational drugs at the time of enrollment, or within 5 half- lives of enrollment or within 3 months to study day 1, whichever is longer.
- History of currently active or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
- Subjects currently or previously diagnosed with cancer or who finished their cancer treatment within 2 years of the start of the clinical trial.
- Subjects with the history of bone marrow, hematopoietic stem cells, or solid organ transplantation.
Show all 11Show fewer
- Has a currently active or known history of meningococcal disease or N. meningitidis infection.
- Evidence of active malignant disease or malignancies diagnosed within the previous 5 year
- Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.
- Pregnant, planning to become pregnant, or nursing female subjects.
- Females with a positive pregnancy test result at Screening or on Day 1.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Proof-of-Concept Phase II, Open-Label Study of NM8074 in Patients with Dermatomyositis (DM)
This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM).
Read the detailed description
The Proposed Study, NM8074-DM-701 will enroll a planned number of eight (8) DM subjects, with the potential to enroll more patients. The total duration of the study for all subjects will include a 30-day screening period, dosing for a 12-week Treatment Period, followed by an observation period of 6-weeks. All subjects will be administered 20 mg/kg of NM8074 intravenously every week for a total of 12 doses from Day 1 to Day 78 of the Treatment Period.
- Conditions
- Dermatomyositis
- Being tested
- NM8074
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM8074Drug
NM8074 will be administered as an intravenous infusion at a dose of 20mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | All subjects will be administered 20 mg/kg of NM8074 intravenously every week, for a total of 12 doses from Day 1 to Day 78 of the treatment Period. Receives: Drug: NM8074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline or Percent Change from Baseline in the number of patients whose Total Improvement Score (TIS) has increased by ≥ 20
TIS is a composite measure used in clinical trials that integrates the 6 Core Set Measures (CSM). TIS scores range from 0-100, with 0-19, 20-39, 40-59, and 60-100 indicating no improvement, minimal, moderate, and major improvement respectively.
Measured: Up to Study Day 78
Secondary outcomes (6)
Change from baseline or Percent Change from Baseline in Cutaneous Dermatomyositis Area and Severity Index (CDASI) score
In DM, CDASI is a visual tool for a physician to assess the activity and damage of skin involvement in DM patients. The total activity score ranges from 0 to 100, and the damage score ranges from 0 to 32, wherein both criteria the higher score indicates more severe activity or damage of the disease in the patient.
Measured: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Manual Muscle Testing (MMT-8) parameter
In Manual Muscle testing (MMT-8) eight specific muscle groups strengths are evaluated, each muscle group is scored on a scale from 0 (no movement) to 10 (normal strength), resulting in a maximum total score of 150 with a higher score indicating better muscle strength. Where a score < 136 would indicate muscle weakness significant enough to classify the patient as at risk of DM. MMT-8 can contribute between 0 to 32.5 points to the TIS: If there is a significant improvement in the patient's condition of more than 30% from baseline, the maximum score of 32.5 points is awarded. If the condition worsens or shows only a slight improvement (up to 2% from baseline), then 0 points are given.
Measured: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Physician's Global Activity (PhGA) assessment
The PhGA is scored on a scale from 0 (no evidence of disease activity) to 10 (extremely severe disease), with higher scores indicating greater disease severity.
Measured: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Patient's Global Activity (PtGA) assessment
The PhGA is scored on a scale from 0 (no evidence of disease activity) to 10 (extremely severe disease), with higher scores indicating greater disease severity.
Measured: Up to Study Day 78
Change from Baseline or Percent Change from Baseline Health Assessment Questionnaire (HAQ) score
HAQ can contribute between 0 to 10 points to the TIS:
- If there is a significant improvement in the patient's condition of more than 40% from baseline, the maximum score of 10 points is awarded. If the condition worsens or shows only a slight improvement (up to 5% from baseline), then 0 points are given.
Measured: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Extra muscular Activity (MDAAT) score
Extra-muscular Activity can contribute between 0 to 20 points to the TIS:
- If there is a significant improvement in the patient's condition of more than 40% from baseline, the maximum score of 20 points is awarded. If the condition worsens or shows only a slight improvement (up to 5% from baseline), then 0 points are given.
Measured: Up to Study Day 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startJun 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed trial in DM subjects is designed as an open-label study.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovelMed Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887738
- Sponsor's protocol ID
- NM8074-DM-701
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Torre IG, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project consortium, The Euromyositis register and The Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann Rheum Dis. 2017 Dec;76(12):1955-1964. doi: 10.1136/annrheumdis-2017-211468. Epub 2017 Oct 27.
PubMed 29079590
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Phase II, Open-Label Study of NM8074 in Patients with Dermatomyositis (DM)
- ClinicalTrials.gov ID
- NCT06887738
- Acronym / sponsor ID
- NM8074-DM-701
- Conditions
- Dermatomyositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- NovelMed TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Mar 2025 (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.
This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM).
Detailed description
The Proposed Study, NM8074-DM-701 will enroll a planned number of eight (8) DM subjects, with the potential to enroll more patients. The total duration of the study for all subjects will include a 30-day screening period, dosing for a 12-week Treatment Period, followed by an observation period of 6-weeks. All subjects will be administered 20 mg/kg of NM8074 intravenously every week for a total of 12 doses from Day 1 to Day 78 of the Treatment Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed trial in DM subjects is designed as an open-label study.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NM8074All subjects will be administered 20 mg/kg of NM8074 intravenously every week, for a total of 12 doses from Day 1 to Day 78 of the treatment Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients ≥18 years of age at the time of consent.
- A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
- Subjects diagnosed with a probable or definite DM according to 2017 European League Against Rheumatism/American College of Rheumatology (2017 EULAR/ACR).
- Subjects must have proof of vaccination against Neisseria meningitidis (MenACWY and MenB), Streptococcus pneumoniae (PCV13 or PCV15 and PPSV23), and Haemophilus influenzae type b (Hib) taken at least 2 weeks prior to NM8074 administration as per national and local guidelines. If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.
- Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for at least 8 weeks after stopping the investigational drug.
Key exclusion criteria (11 listed)
- Subjects with drug-induced myositis
- Subjects who have interstitial lung disease requiring the use of supplemental oxygen.
- Use of other investigational drugs at the time of enrollment, or within 5 half- lives of enrollment or within 3 months to study day 1, whichever is longer.
- History of currently active or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
- Subjects currently or previously diagnosed with cancer or who finished their cancer treatment within 2 years of the start of the clinical trial.
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 |
|---|---|---|
| NM8074NM8074 will be administered as an intravenous infusion at a dose of 20mg/kg | Drug | Cohort 1 |
Primary outcome
Change from Baseline or Percent Change from Baseline in the number of patients whose Total Improvement Score (TIS) has increased by ≥ 20
Time frame: Up to Study Day 78
TIS is a composite measure used in clinical trials that integrates the 6 Core Set Measures (CSM). TIS scores range from 0-100, with 0-19, 20-39, 40-59, and 60-100 indicating no improvement, minimal, moderate, and major improvement respectively.
6 secondary outcomes
Change from baseline or Percent Change from Baseline in Cutaneous Dermatomyositis Area and Severity Index (CDASI) score
Time frame: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Manual Muscle Testing (MMT-8) parameter
Time frame: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Physician's Global Activity (PhGA) assessment
Time frame: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Patient's Global Activity (PtGA) assessment
Time frame: Up to Study Day 78
Change from Baseline or Percent Change from Baseline Health Assessment Questionnaire (HAQ) score
Time frame: Up to Study Day 78
Change from Baseline or Percent Change from Baseline in Extra muscular Activity (MDAAT) score
Time frame: Up to Study Day 78
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 29079590Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Torre IG, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project consortium, The Euromyositis register and The Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann Rheum Dis. 2017 Dec;76(12):1955-1964. doi: 10.1136/annrheumdis-2017-211468. Epub 2017 Oct 27.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dermatomyositis
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NM8074 in people with Dermatomyositis, run by NovelMed Therapeutics.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rekha Bansal (216-440-2696, clinicalsae@novelmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline or Percent Change from Baseline in the number of patients whose Total Improvement Score (TIS) has increased by ≥ 20 (time frame: Up to Study Day 78). 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 NCT06887738, 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 25 Mar 2025.