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Monoclonal Antibodies
Daxdilimab for Inflammatory Myositis
Phase 2
Recruiting
Research Sponsored by Horizon Therapeutics Ireland DAC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day1) to week 24
Awards & highlights
Study Summary
This trial evaluates the effectiveness of a drug (daxdilimab) to reduce symptoms, and its safety and tolerability.
Who is the study for?
This trial is for adults aged 18-75 with a diagnosis of dermatomyositis (DM) or anti-synthetase inflammatory myositis (ASIM), meeting specific criteria like muscle weakness and elevated muscle enzymes. Participants must not have severe infections, other connective tissue diseases that affect assessment, significant organ damage, or be pregnant. They should agree to potentially taper off corticosteroids.Check my eligibility
What is being tested?
The study tests Daxdilimab's effectiveness compared to a placebo in reducing disease activity by week 24. It also looks at its impact on skin symptoms and the possibility of lowering corticosteroid use. Additionally, it will assess how the body processes the drug and any potential immune response to it.See study design
What are the potential side effects?
While not explicitly listed here, common side effects may include reactions at the injection site, increased risk of infection due to immune system suppression, possible liver enzyme changes, fatigue, headache, and gastrointestinal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day1) to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day1) to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of daxdilimab compared to placebo as measured by Total Improvement Score (TIS)
Secondary outcome measures
Change in the cutaneous dermatomyositis disease area and severity index (CDASI) activity score from Baseline (Day 1) to Week 24
Incidence of ADA directed against daxdilimab over time
Incidence of treatment emergent adverse events (TEAEs)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DaxdilimabExperimental Treatment1 Intervention
Daxdilimab will be administered by subcutaneous (SC) injection over a total of 44 weeks.
Group II: PlaceboPlacebo Group2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daxdilimab
2022
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,380 Total Patients Enrolled
Adina Kay Knight, MDStudy DirectorHorizon Therapeutics
Medical Director, MDStudy DirectorHorizon Therapeutics
77 Previous Clinical Trials
16,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have myositis with another connective tissue disease, making treatment response hard to assess.I have had significant heart problems in the last 6 months.I have not been hospitalized or needed IV antibiotics for an infection in the last 2 years.I am currently experiencing active muscle inflammation.I use a wheelchair for mobility.I do not have a skin condition that could affect study assessments, except for DM or ASIM.My weight is over 160 kg (352 pounds).I have a history of primary immunodeficiency or HIV.I have had cancer within the last 5 years.I am between 18 and 75 years old.I do not have any joint or muscle diseases that could affect my treatment evaluation.I am willing to adjust my corticosteroid dose as per the study's guidelines if my condition is stable or getting better.I am on a stable treatment plan, or have stopped medications due to side effects.I have active TB or a positive TB blood test.I have a condition that makes me more likely to get infections.My organs or muscles are severely affected by my condition.I have severe lung scarring or worsening lung fibrosis.I have been diagnosed with a specific muscle disease.
Research Study Groups:
This trial has the following groups:- Group 1: Daxdilimab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial open to seniors aged 55 and above?
"This trial requires that patients be between 18 and 75 years old to meet the enrollment qualifications."
Answered by AI
Who are the permissible participants for this clinical investigation?
"To be eligible to partake in this trial, applicants must have inflammatory myositis and be between 18-75 years of age. A total of 96 participants are desired for the study."
Answered by AI
Are there any available spots for participants in this research project at the moment?
"According to clinicaltrials.gov, this research endeavor is currently recruiting volunteers; it was first published on April 1st 2023 and its details were most recently modified on March 31st 2023."
Answered by AI
Has the FDA granted endorsement to Daxdilimab?
"The safety profile of Daxdilimab was assigned a rating of 2, which is indicative that there exists some data to support its security but no proof indicating efficacy yet."
Answered by AI
What is the current capacity for patients to join this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, published on April 1st 2023, is still looking for volunteers to join the study. A total of 96 participants are needed and can be enrolled from a single site location."
Answered by AI
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