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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of daxdilimab compared to placebo as measured by Total Improvement Score (TIS)
. 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.
. Weight \> 160 kg (352 pounds) at screening.
. 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.