A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

NCT02326272 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: PS00022014-003486-14
• Study Type: interventional
• Target: 227
• Locations: 4 countries
• Sites: 23

Brief Summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.

Conditions

Psoriasis; Plaque Psoriasis

Keywords

Certolizumab Pegol; Cimzia; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16

  The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.

  Week 16

• Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16

  The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  Week 16

Secondary Outcomes (4)

• Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16

  Week 16

• Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48

  Week 48

• Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48

  Week 48

• Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  Week 16

Study Arms (3)

CZP 200 mg

EXPERIMENTAL

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

Biological: Certolizumab Pegol

CZP 400 mg

EXPERIMENTAL

CZP 400 mg every two weeks (Q2W) through Week 14. Treatment received from Week 16 - 48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Subjects who achieve a PASI75 response during the OLE Phase may switch to CZP 200 mg Q2W.

Biological: Certolizumab Pegol

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (sc) injection every two weeks (Q2W). Treatment received from Week 16 - 48 is based on initial treatment and response to treatment: * PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continue to receive Placebo. * PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study. Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Other: Placebo

Interventions

Certolizumab Pegol BIOLOGICAL

* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use

Also known as: Cimzia, CDP870, CZP

CZP 200 mg; CZP 400 mg

Placebo OTHER

* Active Substance: Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use

Also known as: PBO

Placebo

Eligibility Criteria

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

You may qualify if:

• Provided informed consent
• Adult men or women \>= 18 years
• Chronic plaque psoriasis for at least 6 months
• Baseline psoriasis activity and severity index \>= 12 and body surface area \>= 10 % and Physician's Global Assessments score \>= 3
• Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

You may not qualify if:

• Erythrodermic, guttate, generalized pustular form of psoriasis
• History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
• Congestive heart failure
• History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
• Concurrent malignancy or a history of malignancy as described in the protocol
• History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
• Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (23)

Ps0002 203

Phoenix, Arizona, 85032, United States

Location

Ps0002 214

Bakersfield, California, 93309, United States

Location

Ps0002 212

Santa Monica, California, 90404, United States

Location

Ps0002 204

Ormond Beach, Florida, 32174, United States

Location

Ps0002 207

Portsmouth, New Hampshire, 03801, United States

Location

Ps0002 202

East Windsor, New Jersey, 08520, United States

Location

Ps0002 210

New York, New York, 10025, United States

Location

Ps0002 206

Rochester, New York, 14623, United States

Location

Ps0002 209

Wilmington, North Carolina, 28405, United States

Location

Ps0002 205

Cleveland, Ohio, 44106, United States

Location

Ps0002 200

Portland, Oregon, 97223, United States

Location

Ps0002 201

Greer, South Carolina, 29650, United States

Location

Ps0002 208

San Antonio, Texas, 78213, United States

Location

Ps0002 213

Richmond, Virginia, 23294, United States

Location

Ps0002 253

Graz, Styria, Austria

Location

Ps0002 221

Barrie, Ontario, Canada

Location

Ps0002 223

London, Ontario, Canada

Location

Ps0002 222

Peterborough, Ontario, Canada

Location

Ps0002 220

Richmond Hill, Ontario, Canada

Location

Ps0002 224

Waterloo, Ontario, Canada

Location

Ps0002 232

Krakow, Lesser Poland Voivodeship, Poland

Location

Ps0002 231

Wroclaw, Poland

Location

Ps0002 230

Kielce, Świętokrzyskie Voivodeship, Poland

Location

Related Publications (4)

• Gottlieb AB, Blauvelt A, Thaci D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13.

  PMID: 29660421 RESULT

• Gisondi P, Gottlieb AB, Elewski B, Augustin M, McBride S, Tsai TF, de la Loge C, Fierens F, Lopez Pinto JM, Tilt N, Lebwohl M. Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2). Dermatol Ther (Heidelb). 2023 Jan;13(1):315-328. doi: 10.1007/s13555-022-00861-4. Epub 2022 Dec 13.

  PMID: 36509889 DERIVED

• Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9.

  PMID: 32652544 DERIVED

• Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

  PMID: 32531798 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844599

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 29, 2014
• Study Start: December 15, 2014
• Primary Completion: January 5, 2016
• Study Completion: September 12, 2018
• Last Updated: October 3, 2019
• Results First Posted: August 13, 2018

Record last verified: 2019-09

Locations

CA (5); AU (1); PL (3); US (14)