A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
NCT ID: NCT02326272
Last Updated: 2019-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
227 participants
INTERVENTIONAL
2014-12-15
2018-09-12
Brief Summary
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Detailed Description
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* Initial Treatment Period from Week 0 to Week 16
* Maintenance Treatment Period from Week 16 to Week 48
* Open-label Treatment Period from Week 48 to Week 144
* Safety Follow-Up Period from Week 144 to Week 152
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CZP 200 mg
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 Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.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.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
CZP 400 mg
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.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Placebo
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.
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use
Interventions
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Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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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Ps0002 203
Phoenix, Arizona, United States
Ps0002 214
Bakersfield, California, United States
Ps0002 212
Santa Monica, California, United States
Ps0002 204
Ormond Beach, Florida, United States
Ps0002 207
Portsmouth, New Hampshire, United States
Ps0002 202
East Windsor, New Jersey, United States
Ps0002 210
New York, New York, United States
Ps0002 206
Rochester, New York, United States
Ps0002 209
Wilmington, North Carolina, United States
Ps0002 205
Cleveland, Ohio, United States
Ps0002 200
Portland, Oregon, United States
Ps0002 201
Greer, South Carolina, United States
Ps0002 208
San Antonio, Texas, United States
Ps0002 213
Richmond, Virginia, United States
Ps0002 253
Graz, Styria, Austria
Ps0002 221
Barrie, Ontario, Canada
Ps0002 223
London, Ontario, Canada
Ps0002 222
Peterborough, Ontario, Canada
Ps0002 220
Richmond Hill, Ontario, Canada
Ps0002 224
Waterloo, Ontario, Canada
Ps0002 232
Krakow, Lesser Poland Voivodeship, Poland
Ps0002 231
Wroclaw, , Poland
Ps0002 230
Kielce, Świętokrzyskie Voivodeship, Poland
Countries
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References
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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.
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.
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.
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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-003486-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0002
Identifier Type: -
Identifier Source: org_study_id
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