A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Public ClinicalTrials.gov record NCT04044690. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.
Study identification
- NCT ID
- NCT04044690
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2019 (Actual)
- Primary completion
- Dec 2, 2024 (Actual)
- Completion
- Dec 2, 2024 (Actual)
- Last update posted
- Dec 9, 2025
2019 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 8401117 - Arizona Arthritis & Rheumatology Research | Glendale | Arizona | 85306 | — |
| 8401199 - Neuromuscular Research Center | Phoenix | Arizona | 85028 | — |
| 8401129 - UCLA - Rheumatology Los Angeles | Los Angeles | California | 90095 | — |
| 8401473 - RecioMed Clinical Research Network, Inc. | Boynton Beach | Florida | 33472 | — |
| 8401160 - Center For Rheumatology | Fort Lauderdale | Florida | 33334 | — |
| 8401132 - Omega Research Maitland | Orlando | Florida | 32810 | — |
| 8401107 - Morsani Center for Advanced Health Care (CAHC) | Tampa | Florida | 33616 | — |
| 8401152 - The University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| 8401476 - DS Research | Louisville | Kentucky | 40241 | — |
| 8401487 - Ohio State University | Columbus | Ohio | 43210 | — |
| 8401486 - Oregon Health and Science University | Portland | Oregon | 97239 | — |
| 8401210 - University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| 8401151 - Biomedical Science Tower | Pittsburgh | Pennsylvania | 15261 | — |
| 8401474 - West Tennessee Research Institute, LLC | Jackson | Tennessee | 38305 | — |
| 8401115 - The University of Texas Medical School at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04044690, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04044690 live on ClinicalTrials.gov.