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A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02804763
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief 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 receiving stable standard-of-care medications.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus (SLE) Drug: Placebo Drug: Dapirolizumab pegol (DZP) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2, 2016
Actual Primary Completion Date : May 31, 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Standard-of-care + Placebo
Placebo in a specified sequence for a total of 24 weeks
Drug: Placebo
Solution for infusion, 0,9% saline

Experimental: Standard-of-care + DZP dose 1
Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
Drug: Dapirolizumab pegol (DZP)
Solution for infusion

Experimental: Standard-of-care + DZP dose 2
Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
Drug: Dapirolizumab pegol (DZP)
Solution for infusion

Experimental: Standard-of-care + DZP dose 3
Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
Drug: Dapirolizumab pegol (DZP)
Solution for infusion




Primary Outcome Measures :
  1. Percentage of subjects with British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. The percentage of subjects with BICLA response in the individual dose groups at Week 24 [ Time Frame: Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by 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 anti-ENA confirmed by central laboratory
  • The subject is receiving stable SLE standard-of-care medication

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804763


  Hide Study Locations
Locations
United States, Alabama
Sl0023 312
Birmingham, Alabama, United States, 35294
United States, California
Sl0023 307
El Cajon, California, United States, 92020
Sl0023 309
El Cajon, California, United States, 92020
Sl0023 323
Huntington Beach, California, United States, 92646
Sl0023 311
Los Angeles, California, United States, 90048
Sl0023 314
Thousand Oaks, California, United States, 91360
Sl0023 302
Upland, California, United States, 91786
United States, Connecticut
Sl0023 326
New Haven, Connecticut, United States, 06520
United States, Florida
Sl0023 304
Clearwater, Florida, United States, 33765
Sl0023 322
DeBary, Florida, United States, 32713
Sl0023 301
Miami Lakes, Florida, United States, 33014
Sl0023 321
Miami, Florida, United States, 33136
Sl0023 319
Palm Harbor, Florida, United States, 34684
Sl0023 310
Tampa, Florida, United States, 33603
United States, Georgia
Sl0023 324
Atlanta, Georgia, United States, 30303
Sl0023 327
Stockbridge, Georgia, United States, 30281
United States, Idaho
Sl0023 320
Idaho Falls, Idaho, United States, 83404
United States, New Mexico
Sl0023 306
Albuquerque, New Mexico, United States, 87104
United States, New York
Sl0023 313
Lake Success, New York, United States, 11042
United States, Oklahoma
Sl0023 305
Oklahoma City, Oklahoma, United States, 73101
United States, Tennessee
Sl0023 315
Jackson, Tennessee, United States, 38305
Sl0023 308
Memphis, Tennessee, United States, 38119
United States, Texas
Sl0023 317
Amarillo, Texas, United States, 79124
Sl0023 303
Houston, Texas, United States, 77034
United States, Washington
Sl0023 328
Spokane, Washington, United States, 99204
Bulgaria
Sl0023 101
Plovdiv, Bulgaria
Sl0023 102
Plovdiv, Bulgaria
Chile
Sl0023 202
Providencia, Chile
Sl0023 203
Providencia, Chile
Sl0023 201
Puerto Varas, Chile
Sl0023 204
Vina del Mar, Chile
Colombia
Sl0023 213
Barranquilla, Colombia
Sl0023 212
Bogotá, Colombia
Sl0023 214
Bogotá, Colombia
Sl0023 216
Bucaramanga, Colombia
Sl0023 211
Chía, Colombia
Sl0023 215
Medellín, Colombia
Germany
Sl0023 341
Hannover, Germany
Sl0023 113
Leipzig, Germany
Hungary
Sl0023 124
Debrecen, Hungary
Mexico
Sl0023 225
Guadalajara, Mexico
Sl0023 224
León, Mexico
Sl0023 221
Mexico, Mexico
Sl0023 222
San Luis Potosí, Mexico
Peru
Sl0023 232
Arequipa, Peru
Sl0023 231
Lima, Peru
Sl0023 234
Lima, Peru
Sl0023 235
Lima, Peru
Poland
Sl0023 133
Bytom, Poland
Sl0023 136
Lublin, Poland
Sl0023 131
Poznan, Poland
Sl0023 134
Sosnowiec, Poland
Sl0023 135
Warszawa, Poland
Sl0023 138
Łódź, Poland
Romania
Sl0023 146
Brasov, Romania
Sl0023 142
Bucuresti, Romania
Sl0023 144
Cluj-Napoca, Romania
Sl0023 141
Galati, Romania
Russian Federation
Sl0023 157
Kazan, Russian Federation
Sl0023 156
Kemerovo, Russian Federation
Sl0023 152
Saint Petersburg, Russian Federation
Sl0023 155
Voronezh, Russian Federation
Sl0023 151
Yaroslavl', Russian Federation
Sl0023 153
Yekaterinburg, Russian Federation
Spain
Sl0023 161
Barcelona, Spain
Sl0023 162
Madrid, Spain
Sl0023 166
Tenerife, Spain
Ukraine
Sl0023 172
Kyiv, Ukraine
Sl0023 175
Kyiv, Ukraine
Sl0023 171
Odessa, Ukraine
Sl0023 173
Vinnytsya, Ukraine
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02804763     History of Changes
Other Study ID Numbers: SL0023
2015-004457-40 ( EudraCT Number )
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Systemic Lupus Erythematosus (SLE)
Dapirolizumab Pegol (DZP)

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases