Trial · NCT04294667
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
NCT04294667, Phase 3, Completed, UCB Biopharma SRL; results first posted 2025-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus. Trials, record NCT04294667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04294667
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
- NCT number
- NCT04294667
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 321 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- DZP, Placebo
- First posted
- 2020-03-04
- Last updated
- 2025-05-04
- Other registries' IDs
- eudract:2019-003406-27
- Results first posted
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 | Week 48 | Study participants were considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following were fulfilled: * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[≤\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as \[≤\] 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). |
| Secondary | Percentage of Participants With Achievement of BICLA Response at Week 24 | Week 24 | Study participants were considered to be a BICLA responder if all of the following were fulfilled: * BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the PGA compared to Baseline Visit defined as ≤ 10 mm increase on a 100 mm VAS. |
| Secondary | Percentage of Participants With Achievement of BICLA Response at Week 12 | Week 12 | Study participants were considered to be a BICLA responder if all of the following were fulfilled: * BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active and * No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the PGA compared to Baseline Visit defined as ≤ 10 mm increase on a 100 mm VAS. |
| Secondary | Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | A severe BILAG flare was defined as a british isles lupus assessment group disease activity index 2004 (BILAG 2004) Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and were qualifying for the Grade A were according to the supplementary information for the numerical scoring of the BILAG-2004 index. Here, Grade A ("Active"): Severely active disease (sufficient to require systemic immunosuppressant or anticoagulant therapy. |
| Secondary | Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 | During Treatment Period up to Week 48 | The LLDAS includes domains that capture the absence of organ-threatening disease activity and harmful treatment burden. The LLDAS is defined as: * SLEDAI-2K score was ≤4 with no activity in major organ systems. * No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at the previous visit. * PGA ≤ 33 mm. * Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤ 7.5 mg per day. * Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol, defined as no increase in dose in the past 12 weeks and no dose higher than allowed as per protocol. |
| Secondary | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48 | From Baseline (Day 1) to Week 48 | The SLEDAI-2K is a global index which includes 24 clinical and laboratory variables such as antibodies, renal, and hematological components measured 30 days before, and at the timepoint of assessment. The variables were weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies (anti-dsDNA positive or negative) and low complement, as well as some renal and hematologic parameters. The total score falls between 0 and 105, with higher scores representing increased disease activity. Mixed effects models for repeated measurements (MMRM). |
| Secondary | Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48 | Week 48 | The BILAG improvement without worsening defined as A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B Score. Here, score A ("Active"): Severely active disease (sufficient to require systemic immunosuppressant or anticoagulant therapy; score B ("Beware"): Moderately active disease (requires low dose or local immunosuppressant therapy or symptomatic therapy; score C ("Contentment"): Mild stable disease (no indication for changes in treatment); score D ("Discount"): Inactive now but previously active. |
| Secondary | Change From Baseline in Physician's Global Assessment (PGA) at Week 48 | From Baseline (Day 1) to Week 48 | The PGA is a measure of systemic lupus erythematosus (SLE) signs and symptoms by the physician using a visual analog scale of 0 to 100mm, Where 0 indicate "very good", asymptomatic, and no limitation of normal activity and 100 indicate "severe disease". |
| Secondary | Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48 | Week 48 | The SRI-4 define responders as meeting all of the following criteria: * Reduction in SLEDAI-2K score of ≥ 4. * No shift from BILAG 2004 Grade B, C, D, or E to A post-Baseline. Here, Grade A ("Active"): Severely active disease; Grade B ("Beware"): Moderately active disease; Grade C ("Contentment"): Mild stable disease; Grade D ("Discount"): Inactive now but previously active; Grade E ("Excluded"): Never affected. * No more than 1 shift from BILAG 2004 Grade C, D, or E to B post-Baseline. * No worsening in the PGA compared to study entry defined as ≤ 10 mm increase on a 100 mm visual analog scale, equivalent to less than a 10 mm increase in the PGA compared to study entry score. |
| Secondary | Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | Achievement of prevention of moderate/severe BILAG flares through Week 48 was defined as the percentage of participants with no moderate or severe flare through Week 48. A severe BILAG flare was defined as a BILAG 2004 Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and were qualifying for the Grade A, according to the supplementary information for the numerical scoring of the BILAG-2004 index. A moderate BILAG flare was defined as 2 or more BILAG 2004 Grade B due to individual items that were new or worse and were qualifying for the Grade B in any system. Determination of items that were new or worse qualifying for the Grade B, according to the supplementary information for the numerical scoring of the BILAG- 2004 index. Here, Grade A ("Active"): Severely active disease; Grade B ("Beware"): Moderately active disease. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 | Week 48 | The Full Analysis Set (FAS) consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent Good Clinical Practice (GCP) non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Achievement of BICLA Response at Week 24 | Week 24 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Achievement of BICLA Response at Week 12 | Week 12 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 | During Treatment Period up to Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48 | From Baseline (Day 1) to Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48 | Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Physician's Global Assessment (PGA) at Week 48 | From Baseline (Day 1) to Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48 | Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | The FAS consisted of all study participants randomized into the study except 6 participants excluded from FAS due to persistent GCP non-compliance at the site enrolling them. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 | PBO+SOC | 34.6 | percentage of participants | ||
| Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 | DZP+SOC | 49.5 | percentage of participants | ||
| Percentage of Participants With Achievement of BICLA Response at Week 24 | PBO+SOC | 38.3 | percentage of participants | ||
| Percentage of Participants With Achievement of BICLA Response at Week 24 | DZP+SOC | 46.6 | percentage of participants | ||
| Percentage of Participants With Achievement of BICLA Response at Week 12 | PBO+SOC | 29.0 | percentage of participants | ||
| Percentage of Participants With Achievement of BICLA Response at Week 12 | DZP+SOC | 39.9 | percentage of participants | ||
| Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 | PBO+SOC | 76.6 | percentage of participants | ||
| Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 | DZP+SOC | 88.4 | percentage of participants | ||
| Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 | PBO+SOC | 15.9 | percentage of participants | ||
| Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 | DZP+SOC | 23.6 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PBO+SOC | 108 | |
| Overall Study | STARTED | DZP+SOC | 213 | |
| Overall Study | COMPLETED | PBO+SOC | 91 | |
| Overall Study | COMPLETED | DZP+SOC | 192 | |
| Overall Study | NOT COMPLETED | PBO+SOC | 17 | |
| Overall Study | NOT COMPLETED | DZP+SOC | 21 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | PBO+SOC | 10 | 108 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | DZP+SOC | 15 | 213 | 15 |
| other | Nausea | Gastrointestinal disorders | PBO+SOC | 6 | 108 | 9 |
| other | Nausea | Gastrointestinal disorders | DZP+SOC | 9 | 213 | 9 |
| other | COVID-19 | Infections and infestations | PBO+SOC | 17 | 108 | 18 |
| other | COVID-19 | Infections and infestations | DZP+SOC | 44 | 213 | 44 |
| other | Herpes zoster | Infections and infestations | PBO+SOC | 6 | 108 | 7 |
| other | Herpes zoster | Infections and infestations | DZP+SOC | 4 | 213 | 4 |
| other | Oral herpes | Infections and infestations | PBO+SOC | 6 | 108 | 8 |
| other | Oral herpes | Infections and infestations | DZP+SOC | 4 | 213 | 4 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PBO+SOC | 0 | 108 |
| Total, all-cause mortality | DZP+SOC | 1 | 213 |
| Total, other adverse events | PBO+SOC | 47 | 108 |
| Total, other adverse events | DZP+SOC | 109 | 213 |
| Total, serious adverse events | PBO+SOC | 16 | 108 |
| Total, serious adverse events | DZP+SOC | 21 | 213 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42214397 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PBO+SOC vs DZP+SOC: deaths from any cause | Trial comparisons |
| PBO+SOC vs DZP+SOC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04294667
GET https://conductscience.org/api/trials/v1/NCT04294667/results?page=2