Systemic Lupus Erythematosus (SLE)Phase 2NCT02804763
A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
A Phase 2 study testing Dapirolizumab pegol (DZP) in people with Systemic Lupus Erythematosus (SLE), run by UCB Biopharma S.P.R.L. at 71 sites in 13 countries.
Trial summary
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Dapirolizumab pegol (DZP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 71 sitesin 13 countries
- Study dates
- 2 Jun 2016to 19 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
- Moderate to severe SLE disease activity
- Evidence for at least 1 of the following SLE markers:
- Anti-dsDNA antibodies confirmed by central laboratory or
- Low complement confirmed by central laboratory or
- Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory
- The subject is receiving stable SLE standard-of-care medication
Who cannot join
- Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
- Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
- New or worsening Class III or IV lupus nephritis
- Chronic kidney failure stage 3b
- Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
- Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
Show all 10Show fewer
- Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
- Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
- History of thromboembolic events within 12 months of screening
- Subject has used protocol defined prohibited medications
Trial locations and contacts
71 sites in 13 countries.
71 sites in 13 countries
United States25 sites
Sl0023 306
Albuquerque, New Mexico, 87104
Sl0023 317
Amarillo, Texas, 79124
Sl0023 324
Atlanta, Georgia, 30303
Sl0023 312
Birmingham, Alabama, 35294
Sl0023 304
Clearwater, Florida, 33765
Sl0023 322
DeBary, Florida, 32713
Sl0023 307
El Cajon, California, 92020
Sl0023 309
El Cajon, California, 92020
Sl0023 303
Houston, Texas, 77034
Sl0023 323
Huntington Beach, California, 92646
Sl0023 320
Idaho Falls, Idaho, 83404
Sl0023 315
Jackson, Tennessee, 38305
Sl0023 313
Lake Success, New York, 11042
Sl0023 311
Los Angeles, California, 90048
Sl0023 308
Memphis, Tennessee, 38119
Sl0023 321
Miami, Florida, 33136
Sl0023 301
Miami Lakes, Florida, 33014
Sl0023 326
New Haven, Connecticut, 06520
Sl0023 305
Oklahoma City, Oklahoma, 73101
Sl0023 319
Palm Harbor, Florida, 34684
Sl0023 328
Spokane, Washington, 99204
Sl0023 327
Stockbridge, Georgia, 30281
Sl0023 310
Tampa, Florida, 33603
Sl0023 314
Thousand Oaks, California, 91360
Sl0023 302
Upland, California, 91786
Colombia6 sites
Sl0023 213
Barranquilla
Sl0023 212
Bogotá
Sl0023 214
Bogotá
Sl0023 216
Bucaramanga
Sl0023 211
Chía
Sl0023 215
Medellín
Poland6 sites
Sl0023 133
Bytom
Sl0023 138
Lodz
Sl0023 136
Lublin
Sl0023 131
Poznan
Sl0023 134
Sosnowiec
Sl0023 135
Warsaw
Russia6 sites
Sl0023 157
Kazan'
Sl0023 156
Kemerovo
Sl0023 152
Saint Petersburg
Sl0023 155
Voronezh
Sl0023 151
Yaroslavl
Sl0023 153
Yekaterinburg
Chile4 sites
Sl0023 202
Providencia
Sl0023 203
Providencia
Sl0023 201
Puerto Varas
Sl0023 204
Viña del Mar
Mexico4 sites
Sl0023 225
Guadalajara
Sl0023 224
León
Sl0023 221
México
Sl0023 222
San Luis Potosí City
Romania4 sites
Sl0023 146
Brasov
Sl0023 142
Bucharest
Sl0023 144
Cluj-Napoca
Sl0023 141
Galati
Ukraine4 sites
Sl0023 172
Kyiv
Sl0023 175
Kyiv
Sl0023 171
Odesa
Sl0023 173
Vinnytsia
Spain3 sites
Sl0023 161
Barcelona
Sl0023 162
Madrid
Sl0023 166
Santa Cruz de Tenerife
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Placebo, Dapirolizumab pegol (DZP)
- Keywords
- Systemic Lupus Erythematosus (SLE), Dapirolizumab Pegol (DZP)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution for infusion, 0,9% saline
Dapirolizumab pegol (DZP)Drug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo in a specified sequence for a total of 24 weeks Receives: Drug: Placebo |
| DZP dose 1 | Experimental | Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks Receives: Drug: Dapirolizumab pegol (DZP) |
| DZP dose 2 | Experimental | Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks Receives: Drug: Dapirolizumab pegol (DZP) |
| DZP dose 3 | Experimental | Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks Receives: Drug: Dapirolizumab pegol (DZP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity.
BICLA response was defined as meeting all of the following criteria:
- BILAG 2004 improvement: 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.
- No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score.
- No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS).
- No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Measured: Week 24
Secondary outcomes (57)
The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
BICLA response was defined as meeting all of the following criteria:
- BILAG 2004 improvement: 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.
- No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score.
- No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS).
- No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Measured: Week 24
Percentage of Participants With at Least One Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Measured: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants With a Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) must have met 1 or more of the following criteria:
- Death
- Life threatening
- Significant or persistent disability/incapacity
- Congenital anomaly/birth defect (including that occurring in a fetus)
- Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
- Initial inpatient hospitalization or prolongation of hospitalization.
Measured: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants With at Least One Adverse Events (AEs) of Interest
Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled.
AEOI (regardless of seriousness):
- Moderate to severe infections, including opportunistic infections and tuberculosis (TB)
- Infusion reactions (including hypersensitivity and anaphylaxis)
- Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis)
- Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness)
- Malignancies.
Measured: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.
Measured: From Baseline (Week 1) until end of the study (Week 48)
Mean Change From Baseline in Systolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Diastolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Pulse Rate
Pulse Rate was measured in beats per minute (beats/min).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Temperature
Temperature was measured in Grad Celsius (°C).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Weight
Weight was measured in kilograms (kg).
Measured: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20
Mean Change From Baseline in Height
Height was measured in centimeters (cm).
Measured: From Baseline (Week 1) to Week 48
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Measured: Screening, Week 4, Week 24, Week 28 and Week 48
Mean Change From Baseline in Hemoglobin
Hemoglobin was measured in grams per liter (g/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Hematocrit
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes
Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Leukocytes
Leukocytes was measured in number of leukocytes per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Basophils
Basophils was measured in number of basophils per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Basophils/Leukocytes
Basophils/Leukocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Eosinophils
Eosinophils was measured in number of eosinophils per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Eosinophils/Leukocytes
Eosinophils/Leukocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Lymphocytes
Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Lymphocytes/Leukocytes
Lymphocytes/Leukocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Monocytes
Monocytes was measured in number of monocytes per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Monocytes/Leukocytes
Monocytes/Leukocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Neutrophils
Neutrophils was measured in number of neutrophils per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Neutrophils/Leukocytes
Neutrophils/Leukocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Platelets
Platelets was measured in number of platelets per liter (10^9/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in CD3/Lymphocytes
CD3/Lymphocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in CD19/Lymphocytes
CD19/Lymphocytes was measured in percentages (%).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Aspartate Aminotransferase
Aspartate Aminotransferase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Alanine Aminotransferase
Alanine Aminotransferase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Alkaline Phosphatase
Alkaline Phosphatase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Gamma Glutamyl Transferase
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Bilirubin
Bilirubin was measured in micromols per liter (µmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Direct Bilirubin
Direct Bilirubin was measured in micromols per liter (µmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Lactate Dehydrogenase
Lactate Dehydrogenase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Creatinine
Creatinine was measured in micromols per liter (µmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Urea Nitrogen
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Sodium
Sodium was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Potassium
Potassium was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Calcium
Calcium was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Phosphate
Phosphate was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Cholesterol
Cholesterol was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Triglycerides
Triglycerides was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Protein
Protein was measured in grams per liter (g/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Albumin
Albumin was measured in grams per liter (g/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Glucose
Glucose was measured in millimoles per liter (mmol/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Lipase, Pancreatic
Lipase, Pancreatic was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Creatine Kinase
Creatine Kinase was measured in units per liter (U/L).
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in pH
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes (/HPF)
Measured: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Leukocytes (/HPF)
Measured: From Baseline (Week 1) to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start2 Jun 2016
- Primary completion31 May 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804763
- Sponsor's protocol ID
- SL0023
- Other IDs
- 2015-004457-40, 2015
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2016
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Acharya C, Magnusson MO, Vajjah P, Oliver R, Zamacona M. Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. J Clin Pharmacol. 2023 Apr;63(4):435-444. doi: 10.1002/jcph.2188. Epub 2023 Jan 9.
PubMed 36453450Morel T, Cano S, Bartlett SJ, Gordon C, Haier B, Regnault A, Schneider M, Stach C, Cleanthous S. The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 3;61(8):3329-3340. doi: 10.1093/rheumatology/keab920.
PubMed 34897375
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02804763
- Acronym / sponsor ID
- SL0023
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Systemic Lupus Erythematosus (SLE), Dapirolizumab Pegol (DZP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in a specified sequence for a total of 24 weeks |
| DZP dose 1 | Experimental | Drug: Dapirolizumab pegol (DZP)Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks |
| DZP dose 2 | Experimental | Drug: Dapirolizumab pegol (DZP)Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks |
| DZP dose 3 | Experimental | Drug: Dapirolizumab pegol (DZP)Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
- Moderate to severe SLE disease activity
- Evidence for at least 1 of the following SLE markers:
- The subject is receiving stable SLE standard-of-care medication
Key exclusion criteria (10 listed)
- Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
- Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
- New or worsening Class III or IV lupus nephritis
- Chronic kidney failure stage 3b
- Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSolution for infusion, 0,9% saline | Drug | Placebo |
| Dapirolizumab pegol (DZP)Solution for infusion | Drug | DZP dose 1, DZP dose 2, DZP dose 3 |
Primary outcome
Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
Time frame: Week 24
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: 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. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as < 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
57 secondary outcomes
The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
Time frame: Week 24
Percentage of Participants With at Least One Adverse Events (AEs)
Time frame: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants With a Serious Adverse Event (SAE)
Time frame: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants With at Least One Adverse Events (AEs) of Interest
Time frame: From Baseline (Week 1) until end of the study (Week 48)
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
Time frame: From Baseline (Week 1) until end of the study (Week 48)
Mean Change From Baseline in Systolic Blood Pressure
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Diastolic Blood Pressure
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Pulse Rate
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Temperature
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Weight
Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20
Mean Change From Baseline in Height
Time frame: From Baseline (Week 1) to Week 48
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Time frame: Screening, Week 4, Week 24, Week 28 and Week 48
Mean Change From Baseline in Hemoglobin
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Hematocrit
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Leukocytes
Time frame: From Baseline (Week 1) to Week 48
Mean Change From Baseline in Basophils
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Mean Change From Baseline in Basophils/Leukocytes
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Mean Change From Baseline in Eosinophils
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Mean Change From Baseline in Eosinophils/Leukocytes
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Mean Change From Baseline in Lymphocytes
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Mean Change From Baseline in Lymphocytes/Leukocytes
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Mean Change From Baseline in Monocytes
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Mean Change From Baseline in Monocytes/Leukocytes
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Mean Change From Baseline in Neutrophils
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Mean Change From Baseline in Neutrophils/Leukocytes
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Mean Change From Baseline in Platelets
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Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
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Mean Change From Baseline in CD3/Lymphocytes
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Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
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Mean Change From Baseline in CD19/Lymphocytes
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Mean Change From Baseline in Aspartate Aminotransferase
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Mean Change From Baseline in Alanine Aminotransferase
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Mean Change From Baseline in Alkaline Phosphatase
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Mean Change From Baseline in Gamma Glutamyl Transferase
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Mean Change From Baseline in Bilirubin
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Mean Change From Baseline in Direct Bilirubin
Time frame: From Baseline (Week 1) to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36453450Acharya C, Magnusson MO, Vajjah P, Oliver R, Zamacona M. Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. J Clin Pharmacol. 2023 Apr;63(4):435-444. doi: 10.1002/jcph.2188. Epub 2023 Jan 9.
- Derived from this study: PubMed 34897375Morel T, Cano S, Bartlett SJ, Gordon C, Haier B, Regnault A, Schneider M, Stach C, Cleanthous S. The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 3;61(8):3329-3340. doi: 10.1093/rheumatology/keab920.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
71 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapirolizumab pegol (DZP) in people with Systemic Lupus Erythematosus (SLE), run by UCB Biopharma S.P.R.L. at 71 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Colombia, Poland, Russia, Chile and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021; AzTrials last refreshed its copy on 26 Oct 2026.