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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761627
• Other study ID #: 20200417
• Secondary ID: 2020-005205-42
• Status: Completed
• Phase: Phase 3
• Start date: March 24, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate pharmacokinetic similarity, 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.

Description:

This is a multi-center study and will enroll approximately 480 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participant has stable moderate to severe plaque psoriasis for at least 6 months

• Participant has a 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 a mean QT internal or abnormal long QT syndrome corrected using Fridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (for female participant) at baseline that, in the opinion of the Investigator, is abnormal or clinically significant

• 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 5 months 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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Ustekinumab
Participants will receive subcutaneous (SC) injection of ustekinumab.
• ABP 654
Participants will receive SC injection of ABP 654.

Locations

Country	Name	City	State
Canada	CCA Medical Research	Ajax	Ontario
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Dr. Irina Turchin PC Inc.	Fredericton	New Brunswick
Canada	Guelph Dermatology Research	Guelph	Ontario
Canada	Dr Wei Jing Loo Medicine Professional Corporation	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	DermEdge Research Inc.	Mississauga	Ontario
Canada	Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office	Newmarket	Ontario
Canada	North York Research Inc. - Dermatology	North York	Ontario
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	Research Toronto	Toronto	Ontario
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Estonia	Confido Private Medical Clinic - General Practice/Medicine	Tallinn	Harjumaa
Estonia	Innomedica OÜ	Tallinn
Estonia	Clinical Research Center	Tartu	Tartumaa
Estonia	Tartu University Hospital	Tartu	Tartumaa
Georgia	,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC	Tbilisi
Georgia	,,Tbilisi Cancer center"LTD	Tbilisi	T'bilisi
Georgia	Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine	Tbilisi	T'bilisi
Georgia	LTD Aversi Clinic	Tbilisi	T'bilisi
Georgia	LTD Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi	T'bilisi
Germany	Dermazentrum Augsburg	Augsburg	Bayern
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Niedersachsen
Germany	Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden	Sachsen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Frankfurt am Main - Klinik für Dermatol	Frankfurt/Main	Hessen
Germany	Derma-Study-Center-FN	Friedrichshafen	Baden-Württemberg
Germany	UK-SH - Lübeck	Lübeck	Schleswig-Holstein
Germany	Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling	Mahlow	Brandenburg
Germany	Praxis Hoffmann	Witten	Nordrhein-Westfalen
Hungary	Qualiclinic Kft	Budapest	Pest
Hungary	UNOMEDICALTRIALS Kft	Budapest	Pest
Hungary	Debreceni Egyetem Klinikai Központ Nagyerdei Campus	Debrecen	Hajdú-Bihar
Hungary	Brgyógyászati és Allergológiai Magánrendelés	Szolnok	Jász-Nagykun-Szolnok
Latvia	J.Kisis LtD	Riga	Rga
Latvia	Riga 1st hospital, Clinic of Dermatology and STD	Riga	Rga
Latvia	Smite Aija doctor practice in dermatology, venereology	Talsi
Poland	RENEW CLINIC Spolka Jawna	Bialystok
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz
Poland	MICS Centrum Medyczne Bydgoszcz	Bydgoszcz
Poland	Centrum Medyczne Pratia Gdynia	Gdynia
Poland	Barbara Rewerska Diamond Clinic	Krakow
Poland	Centrum Medyczne ALL-MED Badania Kliniczne	Krakow	Maopolskie
Poland	Centrum Medyczne Plejady	Krakow	Maopolskie
Poland	Centrum Medyczne PROMED	Krakow
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow
Poland	ETG Siedlce	Siedlce
Poland	RCMed Oddzial Sochaczew	Sochaczew
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Centrum Medyczne Evimed	Warszawa
Poland	MICS Centrum Medyczne Warszawa	Warszawa	Mazowieckie
Poland	RCMed Oddzia Warszawa	Warszawa
Poland	DermMedica Sp. z o.o.	Wroclaw
United States	Hamilton Research, LLC	Alpharetta	Georgia
United States	Zenith Research Inc.	Beverly Hills	California
United States	DS Research	Clarksville	Indiana
United States	Austin Institute for Clinical Research, Inc.	Dripping Springs	Texas
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Encore Research Group-Jacksonville Center for Clinical Resea	Jacksonville	Florida
United States	Altus Research, Inc.	Lake Worth	Florida
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Quest Dermatology Research	Northridge	California
United States	Skin Specialists PC	Omaha	Nebraska
United States	Leavitt Medical Associates of Florida d/b/a Ameriderm Research	Ormond Beach	Florida
United States	Riverchase Dermatology and Cosmetic Surgery	Pembroke Pines	Florida
United States	Austin Institute for Clinical Research, Inc - Dermatology	Pflugerville	Texas
United States	Oregon Medical Research Center	Portland	Oregon
United States	ActivMed Practices & Research, LLC.	Portsmouth	New Hampshire
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Progressive Clinical Research [Texas]	San Antonio	Texas
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Southern California Dermatology, Inc	Santa Ana	California
United States	Olympian Clinical Research	Tampa	Florida
United States	Kansas Medical Clinic, PA	Topeka	Kansas
United States	The Dermatology Group, PC	Verona	New Jersey
United States	Center for Clinical Studies, LTD., LLP	Webster	Texas
United States	Integrated Clinical Trial Services Inc.	West Des Moines	Iowa
United States	Dundee Dermatology	West Dundee	Illinois
United States	Wilmington Dermatology Center	Wilmington	North Carolina
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  Georgia,  Germany,  Hungary,  Latvia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64	AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Primary	Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64	Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Secondary	Time of Maximum Serum Concentration (Tmax) Between Week 52 and Week 64	Tmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Secondary	Serum Trough Concentration at Steady-state (Ctrough,ss) at Week 28, Week 40, and Week 52	Ctrough,ss at weeks 28, 40, and 52 are presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.	Blood samples were taken pre-dose week 28, week 40, and week 52
Secondary	PASI Percent Improvement From Baseline at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI percent improvement is defined as 100 x (value at baseline - value at post-baseline visit) / value at baseline. A positive value indicates PASI improvement. Baseline data were derived based on observed data and at week 64 were derived based on multiple imputation (MI) data. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
Secondary	PASI 75 Response at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of at least 75% qualified a participant as being a PASI 75 responder. Missing PASI 75 responses at week 64 were imputed by non-responder imputation (NRI). Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
Secondary	PASI 100 Response at Week 64	The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling), each graded on a 0 to 4 scale of the lesions, weighted by the area of involvement. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI response was defined as a participant meeting or surpassing a pre-specified threshold for percent improvement in PASI score compared to the baseline PASI score. An improvement of 100% qualified a participant as being a PASI 100 responder. Missing PASI 100 responses at week 64 were imputed by NRI. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (day 1) and week 64
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period	TEAEs during the post-randomization period were defined as AEs that started on or after the first dose of investigational product post-randomization and prior to the end of study. The number of participants who experienced any TEAE, and who experienced a serious TEAE are presented. A serious TEAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically important serious event.	Week 28 to week 64
Secondary	Number of Participants With Events of Interest (EOI): Post-randomization Period	The treatment-emergent EOIs prespecified for this study included serious systemic hypersensitivity reactions, facial palsy, pustular psoriasis, erythrodermic psoriasis, serious infections (including mycobacterial and salmonella infections), malignancy, cardiovascular events, reversible posterior leukoencephalopathy syndrome (RPLS), serious depression including suicidality, and venous thromboembolism.	Week 28 to week 64
Secondary	Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period	The number of participants developing binding or neutralizing ADAs during the post-randomization period is defined as the number of participants in the safety analysis set who had a positive result post-randomization and had never tested positive (i.e., negative or no results) prior to the first dose of post-randomization investigational product and who have at least one ADA result post randomization. A transient antibody results was defined as a positive result during the post-randomization period with a negative result at the participant's last visit tested within the respective study period. Baseline was defined as the last non-missing assessment taken prior to the first dose of investigational product for the study.	Baseline (pre-dose day 1), week 4, week 16, week 28, week 40, week 52 and week 64

External Links

•   AmgenTrials clinical trials website