A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03051217
• Date of registration: 09/02/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
• Scientific title: Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
• Date of first enrolment: February 21, 2017
• Target sample size: 127
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03051217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Japan

Contacts

• Name: UCB Cares
• Affiliation: UCB ([phone])

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject is male or female, >= 20 years of age.

- Institutional Review Board-approved written informed consent form is signed and dated
by the subject.

- Other protocol-defined inclusion criteria may apply.

For subjects with moderate to severe chronic plaque psoriasis (PSO)

- Chronic plaque psoriasis for at least 6 months.

- Baseline Psoriasis Activity and Severity Index (PASI) >=12 and Body Surface Area (BSA)
affected by PSO >=10% and Physician's Global Assessment (PGA) score of 3 or higher.

- Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.

For subjects with generalized pustular PSO or erythrodermic PSO

- Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.

- History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.

- Baseline BSA affected by PSO >=80% if subjects have a diagnosis of erythrodermic PSO.

Exclusion Criteria:

- Female subject who is breastfeeding, pregnant, or plans to become pregnant during the
study or within 5 months following last dose of study drug. Male subject who is
planning a partner pregnancy during the study or within 5 months following the last
dose of study drug.

- Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to
severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are
excluded.

- History of current, chronic, or recurrent infections of viral, bacterial, or fungal
origin as described in the protocol. Also, subjects with a high risk of infection in
the Investigator's opinion.

- History of a lymphoproliferative disorder including lymphoma or current signs and
symptoms suggestive of lymphoproliferative disease.

- History of other malignancy or concurrent malignancy as described in the protocol.

- Class III or IV congestive heart failure

- History of, or suspected, demyelinating disease of the central nervous system (e.g.,
multiple sclerosis or optic neuritis).

- Subject has any other condition which, in the Investigator's judgment, would make the
subject unsuitable for inclusion in the study.

- Concurrent medication restrictions as described in the protocol.

- Subject with known tuberculosis (TB) infection, at high risk of acquiring TB
infection, or with untreated latent tuberculosis infection (LTBI) or current or
history of nontuberculous mycobacterial (NTMB) infection.

- Subject has any protocol defined clinically significant laboratory abnormalities at
the screening

- Other protocol-defined exclusion criteria may apply.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Moderate to Severe Psoriasis

Intervention(s)

Drug: Certolizumab Pegol

Other: Placebo

Primary Outcome(s)

Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Change From Baseline in Itch Numeric Rating Scale at Week 16 [Time Frame: Baseline and Week 16]

Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16 [Time Frame: Week 16]

Plasma Concentration of Certolizumab Pegol (CZP) [Time Frame: Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60]

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [Time Frame: Baseline and Week 16]

Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma [Time Frame: Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60]

Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16 [Time Frame: Week 16]

Secondary ID(s)

PS0017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03051217