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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

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.

Key facts

Study ID

NCT02804763

Run by

UCB Biopharma S.P.R.L.

People needed

182

Starts

2016-06-02

Expected to finish

2018-11-19

Last updated by the study team

2021-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sl0023 307 — El Cajon, California, United States
• Sl0023 309 — El Cajon, California, United States
• Sl0023 323 — Huntington Beach, California, United States
• Sl0023 311 — Los Angeles, California, United States
• Sl0023 314 — Thousand Oaks, California, United States
• Sl0023 302 — Upland, California, United States
• Sl0023 326 — New Haven, Connecticut, United States
• Sl0023 304 — Clearwater, Florida, United States
• Sl0023 322 — DeBary, Florida, United States
• Sl0023 321 — Miami, Florida, United States
• Sl0023 301 — Miami Lakes, Florida, United States
• Sl0023 319 — Palm Harbor, Florida, United States
• Sl0023 310 — Tampa, Florida, United States
• Sl0023 324 — Atlanta, Georgia, United States
• Sl0023 327 — Stockbridge, Georgia, United States
• Sl0023 320 — Idaho Falls, Idaho, United States
• Sl0023 306 — Albuquerque, New Mexico, United States
• Sl0023 313 — Lake Success, New York, United States
• Sl0023 305 — Oklahoma City, Oklahoma, United States
• Sl0023 315 — Jackson, Tennessee, United States
• Sl0023 308 — Memphis, Tennessee, United States
• Sl0023 317 — Amarillo, Texas, United States
• Sl0023 303 — Houston, Texas, United States
• Sl0023 328 — Spokane, Washington, United States
• Sl0023 312 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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