A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
NCT ID: NCT02804763
Last Updated: 2021-06-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2016-06-02
2018-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo in a specified sequence for a total of 24 weeks
Placebo
Solution for infusion, 0,9% saline
DZP dose 1
Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
Dapirolizumab pegol (DZP)
Solution for infusion
DZP dose 2
Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
Dapirolizumab pegol (DZP)
Solution for infusion
DZP dose 3
Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
Dapirolizumab pegol (DZP)
Solution for infusion
Interventions
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Placebo
Solution for infusion, 0,9% saline
Dapirolizumab pegol (DZP)
Solution for infusion
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Sl0023 312
Birmingham, Alabama, United States
Sl0023 307
El Cajon, California, United States
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El Cajon, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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DeBary, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Palm Harbor, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
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Idaho Falls, Idaho, United States
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Albuquerque, New Mexico, United States
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Lake Success, New York, United States
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Oklahoma City, Oklahoma, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Houston, Texas, United States
Sl0023 328
Spokane, Washington, United States
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Providencia, , Chile
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Providencia, , Chile
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Puerto Varas, , Chile
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Viña del Mar, , Chile
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Chía, , Colombia
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Medellín, , Colombia
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Hanover, , Germany
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Leipzig, , Germany
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Debrecen, , Hungary
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Guadalajara, , Mexico
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León, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Arequipa, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bytom, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Sosnowiec, , Poland
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Warsaw, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Galati, , Romania
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Kazan', , Russia
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Kemerovo, , Russia
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Saint Petersburg, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Santa Cruz de Tenerife, , Spain
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
Countries
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References
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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.
Morel 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004457-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0023
Identifier Type: -
Identifier Source: org_study_id
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