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

NCT02804763 | Completed Phase 2 Results DMC

• 2 other identifiers: SL00232015-004457-40
• Study Type: interventional
• Target: 182
• Locations: 13 countries
• Sites: 71

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Systemic Lupus Erythematosus (SLE); Dapirolizumab Pegol (DZP)

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Week 24

Secondary Outcomes (57)

• The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24

  Week 24

• Percentage of Participants With at Least One Adverse Events (AEs)

  From Baseline (Week 1) until end of the study (Week 48)

• Percentage of Participants With a Serious Adverse Event (SAE)

  From Baseline (Week 1) until end of the study (Week 48)

• Percentage of Participants With at Least One Adverse Events (AEs) of Interest

  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)

  From Baseline (Week 1) until end of the study (Week 48)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo in a specified sequence for a total of 24 weeks

Drug: Placebo

DZP dose 1

EXPERIMENTAL

Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks

Drug: Dapirolizumab pegol (DZP)

DZP dose 2

EXPERIMENTAL

Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks

Drug: Dapirolizumab pegol (DZP)

DZP dose 3

EXPERIMENTAL

Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks

Drug: Dapirolizumab pegol (DZP)

Interventions

Placebo DRUG

Solution for infusion, 0,9% saline

Placebo

Dapirolizumab pegol (DZP) DRUG

Solution for infusion

DZP dose 1; DZP dose 2; DZP dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (71)

Sl0023 312

Birmingham, Alabama, 35294, United States

Location

Sl0023 307

El Cajon, California, 92020, United States

Location

Sl0023 309

El Cajon, California, 92020, United States

Location

Sl0023 323

Huntington Beach, California, 92646, United States

Location

Sl0023 311

Los Angeles, California, 90048, United States

Location

Sl0023 314

Thousand Oaks, California, 91360, United States

Location

Sl0023 302

Upland, California, 91786, United States

Location

Sl0023 326

New Haven, Connecticut, 06520, United States

Location

Sl0023 304

Clearwater, Florida, 33765, United States

Location

Sl0023 322

DeBary, Florida, 32713, United States

Location

Sl0023 321

Miami, Florida, 33136, United States

Location

Sl0023 301

Miami Lakes, Florida, 33014, United States

Location

Sl0023 319

Palm Harbor, Florida, 34684, United States

Location

Sl0023 310

Tampa, Florida, 33603, United States

Location

Sl0023 324

Atlanta, Georgia, 30303, United States

Location

Sl0023 327

Stockbridge, Georgia, 30281, United States

Location

Sl0023 320

Idaho Falls, Idaho, 83404, United States

Location

Sl0023 306

Albuquerque, New Mexico, 87104, United States

Location

Sl0023 313

Lake Success, New York, 11042, United States

Location

Sl0023 305

Oklahoma City, Oklahoma, 73101, United States

Location

Sl0023 315

Jackson, Tennessee, 38305, United States

Location

Sl0023 308

Memphis, Tennessee, 38119, United States

Location

Sl0023 317

Amarillo, Texas, 79124, United States

Location

Sl0023 303

Houston, Texas, 77034, United States

Location

Sl0023 328

Spokane, Washington, 99204, United States

Location

Sl0023 101

Plovdiv, Bulgaria

Location

Sl0023 102

Plovdiv, Bulgaria

Location

Sl0023 202

Providencia, Chile

Location

Sl0023 203

Providencia, Chile

Location

Sl0023 201

Puerto Varas, Chile

Location

Sl0023 204

Viña del Mar, Chile

Location

Sl0023 213

Barranquilla, Colombia

Location

Sl0023 212

Bogotá, Colombia

Location

Sl0023 214

Bogotá, Colombia

Location

Sl0023 216

Bucaramanga, Colombia

Location

Sl0023 211

Chía, Colombia

Location

Sl0023 215

Medellín, Colombia

Location

Sl0023 341

Hanover, Germany

Location

Sl0023 113

Leipzig, Germany

Location

Sl0023 124

Debrecen, Hungary

Location

Sl0023 225

Guadalajara, Mexico

Location

Sl0023 224

León, Mexico

Location

Sl0023 221

México, Mexico

Location

Sl0023 222

San Luis Potosí City, Mexico

Location

Sl0023 232

Arequipa, Peru

Location

Sl0023 231

Lima, Peru

Location

Sl0023 234

Lima, Peru

Location

Sl0023 235

Lima, Peru

Location

Sl0023 133

Bytom, Poland

Location

Sl0023 138

Lodz, Poland

Location

Sl0023 136

Lublin, Poland

Location

Sl0023 131

Poznan, Poland

Location

Sl0023 134

Sosnowiec, Poland

Location

Sl0023 135

Warsaw, Poland

Location

Sl0023 146

Brasov, Romania

Location

Sl0023 142

Bucharest, Romania

Location

Sl0023 144

Cluj-Napoca, Romania

Location

Sl0023 141

Galati, Romania

Location

Sl0023 157

Kazan', Russia

Location

Sl0023 156

Kemerovo, Russia

Location

Sl0023 152

Saint Petersburg, Russia

Location

Sl0023 155

Voronezh, Russia

Location

Sl0023 151

Yaroslavl, Russia

Location

Sl0023 153

Yekaterinburg, Russia

Location

Sl0023 161

Barcelona, Spain

Location

Sl0023 162

Madrid, Spain

Location

Sl0023 166

Santa Cruz de Tenerife, Spain

Location

Sl0023 172

Kyiv, Ukraine

Location

Sl0023 175

Kyiv, Ukraine

Location

Sl0023 171

Odesa, Ukraine

Location

Sl0023 173

Vinnytsia, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 36453450 DERIVED

• 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.

  PMID: 34897375 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

dapirolizumab pegol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: June 2, 2016
• Primary Completion: May 31, 2018
• Study Completion: November 19, 2018
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

PL (6); US (25); RU (6); UA (4); RO (4); BU (2); ES (3); ME (4); CL (4); CO (6); HU (1); PE (4); DE (2)