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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Horizon Therapeutics Ireland DAC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Adina Kay Knight, MD|
|Principal Investigator Affiliation||Horizon Therapeutics|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Inflammatory Myositis|
The study will enroll 96 participants with 2 idiopathic inflammatory myositis populations:
Daxdilimab will be administered by subcutaneous (SC) injection over a total of 44 weeks.
Placebo Comparator: Placebo
Matching placebo will be administered by SC injection over a total of 24 weeks, then will be administered active drug by SC injection up to Week 44
Drug: - Daxdilimab
Participants will be administered daxdilimab by subcutaneous (SC) injection
Drug: - Placebo
Participants will be administered identically matching placebo by SC injection over a total of 24 weeks, then participants will be given active treatment for the remainder of the study.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Advanced Research Center
Anaheim, California, 92805-5854
Not yet recruiting
Griffith University Austrailia
Spring Hill, , QLD 4000