A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

Official Title
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A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Adalimumab
* Drug: ABP 501


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline Participant has no known history of latent or active tuberculosis Exclusion Criteria: Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis Participant has an active infection or history of infections Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment Participant has received topical psoriasis treatment within 2 weeks prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continued-use Group (Adalimumab)<br>Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28. | Drug: Adalimumab<br>* Participants will receive subcutaneous (SC) injection of adalimumab<br>* Other names: Humira®;|
| Experimental: Switching Group (Adalimumab - ABP 501)<br>Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28. | Drug: Adalimumab<br>* Participants will receive subcutaneous (SC) injection of adalimumab<br>* Other names: Humira®;Drug: ABP 501<br>* Participants will receive SC injection of ABP 501<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of Adalimumab and ABP 501 | To evaluate similarity of AUCtau in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab. | Week 28 (Pre-dose and Post-dose) through Week 30 | 
| Maximum Concentration (Cmax) of Adalimumab and ABP 501 | To evaluate similarity of Cmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab. | Week 28 (Pre-dose and Post-dose) through Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Maximum Concentration (tmax) of Adalimumab and ABP 501 | To evaluate tmax in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab. | Week 28 (Pre-dose and Post-dose) through Week 30 | 
| Trough Concentration (Ctrough) of Adalimumab and ABP 501 | To evaluate Ctrough in participants after multiple switches between adalimumab and ABP 501, compared to participants receiving continued-use of adalimumab. | Week 14 through Week 28 (Pre-dose and Post-dose) | 
| Percent Improvement in PASI From Baseline to Week 30 | The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling); each graded on a 0-4 scale (0 = clear; 1-4= increasing severity) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | Baseline (Day 1) through Week 30 | 
| Percentage of Participants with PASI 75 Response at Week 30 | Reduction in disease as measured by PASI score. The PASI 75 response is a 75% or greater improvement (reduction in disease [PASI 75]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale (0 = clear; 1-4= increasing severity) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | At Week 30 | 
| Percentage of Participants with PASI 90 Response at Week 30 | Reduction in disease as measured by PASI score. The PASI 90 response is a 90% or greater improvement (reduction in disease [PASI 90]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale (0 = clear; 1-4= increasing severity) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | At Week 30 | 
| Percentage of Participants with PASI 100 Response at Week 30 | Reduction in disease as measured by PASI score. The PASI 100 response is a 100% improvement (reduction in disease [PASI 100]) from baseline in PASI score. The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale (0 = clear; 1-4= increasing severity) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | At Week 30 | 
| Number of Participants With Treatment Related Adverse Events (TEAEs) | To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab. | From Screening (≤ 28 days) through Week 32 or End of Study | 
| Number of Participants With Events of Interest | To assess the safety in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab. | From Screening (≤ 28 days) through Week 32 or End of Study | 
| Percentage of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time | To assess the immunogenicity in participants after multiple switches between ABP 501 and adalimumab compared with participants receiving continued-use of adalimumab. | Baseline (Day 1) through Week 32 (Pre-dose) or End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adalimumab, Biosimilars, Tumor necrosis factor, Psoriasis Area and Severity Index