Clinical Trial Results:
A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus
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Summary
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EudraCT number |
2021-000962-14 |
Trial protocol |
DE |
Global end of trial date |
25 Jul 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Apr 2026
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First version publication date |
10 Apr 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CCM-RNT-202101
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04810754 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Charitè - Universitätsmedizin Berlin
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Sponsor organisation address |
Charitéplatz 1, Berlin, Germany, 10117
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Public contact |
Rheumatologie - Studienabteilung, Charité - Universitätsmedizin Berlin, 0049 (0)30450513025, rheumastudien@charite.de
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Scientific contact |
Rheumatologie - Studienabteilung, Charité - Universitätsmedizin Berlin, 0049 (0)30450513025, rheumastudien@charite.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Aug 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Jul 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jul 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate whether treatment with eight weekly subcutaneous injections of daratumumab is associated with a reduction of pathogenic serum anti-dsDNA antibodies in patients with moderate to severe SLE.
Primary objective of the LTE observational period ist to evaluate of the long-term safety of daratumumab, previously administered in the core study period, for the treatment of SLE;
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Protection of trial subjects |
The study was conducted in accordance with the principles of the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Ten patients were enrolled between August 2021 and January 2023 at one site in Germany | ||||||
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Pre-assignment
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Screening details |
10 Patients with elevated anti -dsDNA antibodies in serum and active Systemic Lupus Erythematosus disease were screened an enrolled. | ||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
This was a single-arm, open-label, phase 2 clinical trial.
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Arms
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Arm title
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Daratumumab | ||||||
Arm description |
single-arm, open-label, | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Daratumumab
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Investigational medicinal product code |
JNJ-54767414
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Other name |
Darzalex, EU/3/13/1153
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Patients received eight subcutaneous injections of 1800 mg daratumumab weekly, with dexamethasone as premedication (20mg for first two injections, then 10 mg)
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
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End points reporting groups
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Reporting group title |
Daratumumab
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Reporting group description |
single-arm, open-label, | ||
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End point title |
change anti-dsDNA level [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
from baseline to week 12
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary and secondary outcome measures were analysed according to the intention-to-treat principle. For the primary endpoint analysis, the median is reported for anti-dsDNA antibody titres at baseline and at week 12. The change between the two assess ments was analysed using the non-parametric Wilcoxon signed-rank test and the median difference with 95% CI estimate were calculated.For the immunological data, the Chi-Squared test, Kruskal-Wallis test with Dunn’s test were computed, (charts) |
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Attachments |
primary and secondary endpoints |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
overall trial
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
Daratumumab
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/10427415 |
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