A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participant… (NCT05669014) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
United States, Brazil, Czechia12 participantsStarted 2023-12-04
Plain-language summary
The primary efficacy objective:
To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
The secondary efficacy objectives include:
1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24.
3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24.
Other secondary objectives include:
1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants.
2. To evaluate the safety and tolerability of daxdilimab in participants.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).
✓. A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria:
✓. Population 1: DM
✓. Population 2: ASIM
✓. Currently active myositis with all the following (a, b, and c) during screening:
✓. Manual Muscle Testing (MMT 8) score \< 142
✓. At least 2 other abnormal core set measures (CSM) from the following list:
✓. Global muscle damage score ≤ 5 on a 10 cm VAS on the myositis damage index (MDI).
Exclusion criteria
✕. Any condition that, in the opinion of the investigator or sponsor, would interfere with the evaluation of investigational product (IP) or interpretation of participant safety or study results.
What they're measuring
1
Efficacy of daxdilimab compared to placebo as measured by Total Improvement Score (TIS)
✕. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
✕. History of clinically meaningful cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically meaningful abnormality on electrocardiogram (ECG) if, in the opinion of the Investigator, it would increase the risk of study participation.
✕. History of cancer within the past 5 years except cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
✕. Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection (eg. hepatitis C).
✕. Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
✕. All participants will undergo testing for hepatitis B virus serology as defined in the protocol.