| Study name |
A study to investigate interchangeability of ABP 654 for the treatment of subjects with moderate‐to‐severe plaque psoriasis |
| Methods |
RCT, active‐controlled, double‐blind study
Date of study: March 2021
Location: USA, Canada, Estonia, Germany, Georgia, Latvia, Hungary, Poland, Spain (worldwide)
Phase 3 |
| Participants |
Randomised: 494 participants
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 anti‐psoriatic 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 (e.g. 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 enrolment Participant has received biologic treatment for psoriasis within the previous month or 5 drug half‐lives (whichever is longer) prior to enrolment Participant has received any investigational agents within the previous month or 5 half‐lives (whichever is longer) prior to enrolment Participant has received non‐biologic systemic psoriasis therapy within 4 weeks prior to enrolment Participant has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrolment, or ultraviolet B phototherapy within 2 weeks prior to enrolment Participant has received topical psoriasis treatment within 2 weeks prior to enrolment Participant has received other investigational procedures within 4 weeks prior to enrolment 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
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| Interventions |
Intervention
A. Switching group (ustekinumab ‐ ABP 654); 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.
Control intervention
B. Continued‐use group ustekinumab SC from day 1 to week 52 |
| Outcomes |
Primary outcomes
Area under the curve from time 0 over the dosing interval (AUCtau) (time frame: week 52 (pre‐dose and post‐dose) until week 64) Maximum concentration (Cmax) (time frame: week 52 (pre‐dose and post‐dose) until week 64)
Secondary outcomes
Time of maximum concentration (tmax) (time frame: week 52 (pre‐dose and post‐dose) until week 64) Trough concentration at steady state (Ctrough,ss) (time frame: week 28 (pre‐dose and post‐dose) until week 52 (pre‐dose and post‐dose)) Percent improvement in PASI from baseline to week 64 Percentage of participants with PASI 75 response at week 64 Percentage of participants with PASI 100 response at week 64 Number of participants with treatment‐emergent adverse events and serious adverse events (time frame: week 28 until week 64) Number of participants with events of interest (time frame: week 28 until week 64) Number of participants with positive anti‐drug antibodies to ABP 654 (time frame: week 28 until week 64 (pre‐dose))
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| Starting date |
Study start date: March 2021
Estimated study completion date: March 2023
Last update posted: December 2021, active, not recruiting |
| Contact information |
Amgen Call Center 866‐572‐6436medinfo@amgen.com |
| Notes |
NCT04761627
Last check in October 2022 |
