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Ravulizumab for Dermatomyositis

Phase 2 & 3
Recruiting
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older at the time of signing the informed consent.
Body weight ≥ 30 kilograms at the time of Screening.
Must not have
Evidence of active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors
Participants with other forms of myositis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26

Summary

This trial tests ravulizumab, a medication that helps manage immune system-related conditions, in adults with dermatomyositis. The drug aims to reduce inflammation and prevent muscle and skin damage by calming the immune system.

Who is the study for?
Adults with dermatomyositis who've had a poor response or can't tolerate at least one standard treatment, weigh over 30 kg, and are vaccinated against Neisseria meningitidis. Excludes those with recent cancer, certain infections, fever before the trial starts, HIV infection, severe muscle damage as per investigator's judgment.
What is being tested?
The study is testing Ravulizumab versus a placebo in adults with dermatomyositis to assess its effectiveness and safety. Participants will be randomly assigned to receive either the drug or a placebo without knowing which they're getting (double-blind).
What are the potential side effects?
Potential side effects of Ravulizumab may include reactions related to infusion of the drug into the body, increased risk of infections due to immune system suppression, and possible allergic responses if sensitive to murine proteins or other components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My weight is at least 30 kilograms.
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I am 18 years old or older.
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I weigh at least 30 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with cancer within the last 3 years.
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I have a type of myositis.
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I am HIV positive.
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I have had a fever of 100.4°F or higher in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand
Part B: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand
Secondary study objectives
Part A and B: TIS At Week 26
Part A and Part B: CDASI Response (7-point improvement) at Week 26
Part A and Part B: Change From Baseline In Cutaneous Dermatomyositis Disease Area And Severity Index (CDASI) Activity Score At Week 26
+8 more

Side effects data

From 2022 Phase 4 trial • 18 Patients • NCT04320602
33%
Fatigue
17%
Abdominal pain
17%
SARS-CoV-2 test positive
17%
Cough
17%
COVID-19
11%
Back pain
11%
Nasopharyngitis
11%
Non-cardiac chest pain
11%
Dyspnoea
6%
Chest discomfort
6%
Rash
6%
Retinal haemorrhage
6%
Body temperature abnormal
6%
Influenza like illness
6%
Pain in extremity
6%
Herpes zoster
6%
Haemoglobinuria
6%
Nail ridging
6%
Arthralgia
6%
Peripheral swelling
6%
Pneumonia
6%
Asthenia
6%
Headache
6%
Pain
6%
Neurodermatitis
6%
Skin lesion
6%
Chromaturia
6%
Nephrolithiasis
6%
Pyrexia
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Constipation
6%
Extravascular haemolysis
6%
Haemoglobin decreased
6%
Upper respiratory tract congestion
6%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment1 Intervention
Participants will receive ravulizumab in both Parts A and B.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo in both Parts A and B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2016
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,565 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
38,479 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04999020 — Phase 2 & 3
Dermatomyositis Research Study Groups: Ravulizumab, Placebo
Dermatomyositis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04999020 — Phase 2 & 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999020 — Phase 2 & 3
~61 spots leftby Nov 2026
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