Study of NM8074 in Patients with Dermatomyositis (DM) (NCT06887738) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of NM8074 in Patients with Dermatomyositis (DM)
8 participantsStarted 2026-06
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
What they're measuring
1
Change from Baseline or Percent Change from Baseline in the number of patients whose Total Improvement Score (TIS) has increased by ≥ 20