A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared With Continued Use of Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Sponsors

Lead Sponsor: Amgen

Source Amgen
Brief Summary

The purpose of the study is to evaluate pharmacokinetic equivalence, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.

Detailed Description

This is a multi-center study and will enroll approximately 352 participants. After eligibility confirmation, all participants will be randomized in a 1:1 ratio into 2 treatment arms: continued use of ustekinumab or multiple switches between ustekinumab and ABP 654 at Week 28. The randomization will be stratified by prior biologic use for psoriasis (yes versus [vs] no) at baseline (Week 0), geographic region, and baseline (Week 0) body weight. All participants will receive an initial 3 doses of ustekinumab on Day 1 (Week 0), Week 4 and Week 16. At Week 28, participants will be randomized to continue on ustekinumab or switching between ABP 654 and ustekinumab every 12 weeks. At Week 28, efficacy assessments will be conducted including evaluation of Psoriasis and Area Severity Index (PASI). Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered as run-in failures and will not be randomized at Week 28; these participants will complete End of Study procedures at Week 28. The run-in period will occur from Day 1 until randomization at Week 28. Those unable to complete the Week 28 visit or did not have a PASI assessment completed at Week 28 will be discontinued from the study. The total duration of study participation for each participant will be 68 weeks, with up to 4 weeks for screening and 64 weeks after the first investigational product administration.

Overall Status Not yet recruiting
Start Date February 28, 2021
Completion Date March 20, 2023
Primary Completion Date March 20, 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Area Under the Curve from Time 0 over the Dosing Interval (AUCtau) Week 52 (pre-dose and post-dose) until Week 64
Maximum Concentration (Cmax) Week 52 (pre-dose and post-dose) until Week 64
Secondary Outcome
Measure Time Frame
Time of Maximum Concentration (tmax) Week 52 (pre-dose and post-dose) until Week 64
Trough Concentration at Steady State (Ctrough,ss) Week 28 (pre-dose and post-dose) until Week 52 (pre-dose and post-dose)
Percent Improvement in PASI From Baseline to Week 64 Baseline (Day 1) until Week 64
Percentage of Participants with PASI 75 Response at Week 64 Week 64
Percentage of Participants with PASI 100 Response at Week 64 Week 64
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events Week 28 until Week 64
Number of Participants With Events of Interest Week 28 until Week 64
Number of Participants With Positive Anti-drug Antibodies to ABP 654 Week 28 until Week 64 (Pre-dose)
Enrollment 352
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ustekinumab

Description: Participants will receive subcutaneous (SC) injection of ustekinumab.

Other Name: Stelara®

Intervention Type: Drug

Intervention Name: ABP 654

Description: Participants will receive SC injection of ABP 654.

Arm Group Label: Switching Group (Ustekinumab - ABP 654)

Eligibility

Criteria:

Inclusion Criteria: - Participant has stable moderate to severe plaque psoriasis for at least 6 months - Participant has a baseline score of PASI ≥ 12, involvement of ≥ 10% body surface area and static Physician Global Assessment ≥ 3 at screening and at baseline - Participant is a candidate for phototherapy or systemic therapy - Participant has previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy - Female participant should have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline - Participant or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent - Participant has no known history of latent or active tuberculosis - Participant with a positive purified protein derivative (PPD) test and a history of Bacillus Calmette-Guérin (BCG) vaccination is allowed with a negative Quantiferon/T-spot test - Participant with a positive PPD test or participant with a positive or indeterminate Quantiferon/T-spot test is allowed if he/she has all the following: - No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc. - Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations - No known exposure to a case of active tuberculosis after most recent prophylaxis - No evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product 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 uncontrolled, clinically significant systemic disease, such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension - Participant has moderate to severe heart failure (New York Heart Associate class III/IV) - Participant has known hypersensitivity to the investigational product or to any of the excipients - Participant has laboratory abnormalities at screening - Participant has had previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23 within 1 year prior to enrollment - 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 any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment - Participant has received non-biologic systemic psoriasis therapy within 4 weeks prior to enrollment - Participant has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment - Participant has received topical psoriasis treatment within 2 weeks prior to enrollment - Participant has received other investigational procedures within 4 weeks prior to enrollment and during the course of the study - Female participant is pregnant or breastfeeding or planning to become pregnant while participating in the study and for at least 15 weeks after the last dose of investigational product - Sexually active participants and their partners who are of childbearing potential and not agreeing to use adequate protocol defined contraception methods while participating in the study and for 5 months after the last dose of investigational product

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
MD Study Director Amgen
Overall Contact

Last Name: Amgen Call Center

Phone: 866-572-6436

Email: [email protected]

Location
Facility:
Research Site | Pembroke Pines, Florida, 33028, United States
Research Site | Omaha, Nebraska, 68144, United States
Location Countries

United States

Verification Date

February 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Continued-use Group (Ustekinumab)

Type: Active Comparator

Description: Participants will receive continuous injection of ustekinumab from Day 1 to Week 52.

Label: Switching Group (Ustekinumab - ABP 654)

Type: Experimental

Description: Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Masking Description: The investigators, study personnel (with the exception of the Data Monitoring Committee (DMC), and unblinded Parexel staff supporting DMC activities and randomization list activities) and the study participants will remain blinded to treatment allocation. ABP 654 and ustekinumab will be coded and labeled in a manner that protects blinding.

Source: ClinicalTrials.gov