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

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared With Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607980
• Other study ID #: 20190232
• Secondary ID: 2020-003184-25
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2020
• Est. completion date: June 3, 2022

Study information

• Verified date: November 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.

Description:

This is a multicenter study and will enroll approximately 542 participants.

The total duration of study participation for each participant will be 56 weeks, with up to 4 weeks for screening, and for 52 weeks after the first administration of either ABP 654 or ustekinumab.

After confirmation of eligibility, all participants will be randomized in a 1:1 ratio into 2 treatment groups (Group A will receive ABP 654, and Group B will receive ustekinumab) stratified by prior biologic use for psoriasis (yes versus [vs] no), geographic region, and baseline body weight (BW).

Based on the psoriasis area and severity index (PASI) score (to determine better improvement or partial improvement) at week 28, the participants in the study will proceed as follows:

1. Participants who do not achieve PASI 50 response or better improvement at Week 28 will be considered to have completed the study and will complete end of study procedures (ie, week 52 procedures), and those unable to complete week 28 visit, or did not have a PASI assessment completed, will be discontinued from the study.

2. Participants who achieve PASI 75 response or better improvement will continue on the study and will be re-randomized in a blinded fashion such that participants initially randomized to Group A (ABP 654) will continue to receive ABP 654 and those in Group B (ustekinumab) will re-randomized, to either continue on ustekinumab (Treatment Group B1) or switch to ABP 654 (Treatment Group B2).

3. Participants with PASI 50 response or better but less than PASI 75 response and on the Investigator's decision, participants will continue on the originally assigned treatment with dose intensification and will not be re-randomized. However, participants that do not dose intensify will be re-randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: June 3, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

• Stable moderate to severe plaque psoriasis for at least 6 months

• Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screening and at baseline

• Candidate for phototherapy or systemic therapy

• Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

• Female participants should have negative serum pregnancy test during screening and a negative urine pregnancy test at baseline

• No known history of latent or active tuberculosis (TB), and has a negative test for TB during screening (with negative purified protein derivative (PPD), and Negative Quantiferon®/T-spot test)

• Participants with a positive purified protein derivative and a history of Bacillus Calmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®

• Participants with a positive PPD test (without history of BCG vaccination) or participants with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:

• No symptoms per TB worksheet provided by the sponsor

• Documented history of adequate prophylaxis initiation prior to receiving investigational product (IP) in accordance with local recommendations

• No known exposure to a case of active TB after most recent prophylaxis

• No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustular PsO, guttate PsO, medication induced PsO, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on PsO

• Participant has an active infection, recurrent or chronic infections, serious infection or history of infections

• Known history of human immunodeficiency virus

• Hepatitis B surface antigen or hepatitis C virus antibody positivity at screening

• Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension

• Moderate to severe heart failure (New York Heart Associate class III/IV)

• Known hypersensitivity to the IP or to any of the excipients

• Any abnormal laboratory parameters at screening, as defined in protocol

• Previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23

• Received biologic treatment for psoriasis within the previous month or 5 drug half-lives prior to randomization

• Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization

• Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2 weeks prior to randomization

• Received topical psoriasis treatment within 2 weeks prior to randomization (exception:

upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face, and intertriginous areas; bland emollients)

• Received live viral or live bacterial vaccination within 2 weeks prior to randomization

• Received BCG vaccination within 1 year prior to randomization

• Other investigational procedures within 4 weeks prior to randomization and during the study

• Participants not agreeing to follow protocol defined contraceptives procedures

• Participants likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Canada	CCA Medical Research	Ajax	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Kingsway Clinical Research	Etobicoke	Ontario
Canada	Dermatrials Research Inc	Hamilton	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	DermEdge Research Inc.	Mississauga	Ontario
Canada	North Bay Dermatology Centre Inc.	North Bay	Ontario
Canada	JRB Research Inc.	Ottawa	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche dermatolog	Quebec city	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	Toronto Research Centre - Dermatology	Toronto	Ontario
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario
Canada	XLR8 Medical Research Inc.	Windsor	Ontario
Estonia	Confido Private Medical Clinic - General Practice/Medicine	Tallinn	Harjumaa
Estonia	Vahlberg & Pild OÜ	Tallinn	Harjumaa
Estonia	Clinical Research Center	Tartu	Tartumaa
Estonia	Tartu University Hospital	Tartu	Tartumaa
Germany	Hautzentrum im Jahrhunderthaus	Bochum	Nordrhein-Westfalen
Germany	Derma Zentrum Osnabrueck Nord	Bramsche	Niedersachsen
Germany	Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling	Mahlow	Brandenburg
Germany	CentroDerm GmbH	Wuppertal	Nordrhein-Westfalen
Hungary	UNOMEDICALTRIALS Kft	Budapest	Pest
Hungary	Brgyógyászati és Allergológiai Magánrendelés	Szolnok	Jász-Nagykun-Szolnok
Latvia	Health and Aesthetics Ltd	Riga
Latvia	Health Centre 4 Ltd., Diagnostics Centre	Riga	Rga
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
Lithuania	Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik	Kaunas	Kauno Apskritis
Lithuania	Vilniaus universiteto ligonine Santaros klinikos Dermatovenerologijos centras	Vilnius	Vilniaus Apskritis
Poland	ClinicMed Daniluk, Nowak Sp. J.	Bialystok	Podlaskie
Poland	Specderm Poznanska Sp. j.	Bialystok	Podlaskie
Poland	Zespol Naukowo-Leczniczy Iwolang sp. z.o.o.	Iwonicz Zdroj	Podkarpackie
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Barbara Rewerska Diamond Clinic	Krakow
Poland	Centrum Medyczne ALL-MED	Krakow	Maopolskie
Poland	Centrum Zdrowia i Urody Maxxmed	Lublin
Poland	ETG Lublin	Lublin
Poland	Solumed	Poznan
Poland	ETG Skierniewice	Skierniewice	Ódzkie
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Torun
Poland	ETG Warszawa	Warszawa	Mazowieckie
Poland	Klinika Ambroziak Dermatologia	Warszawa
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Poland	Royalderm Agnieszka Nawrocka	Warszawa	Mazowieckie
Poland	DermMedica Sp. z o.o.	Wroclaw
Poland	WroMedica I. Bielicka, A. Strzalkowska s.c.	Wroclaw
United States	DelRicht Research	Baton Rouge	Louisiana
United States	ALLCUTIS Research, LLC.	Beverly	Massachusetts
United States	Bexley Dermatology Research	Bexley	Ohio
United States	Total Skin and Beauty Dermatology Center PC	Birmingham	Alabama
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	Center for Clinical Studies	Cypress	Texas
United States	Modern Research Associates	Dallas	Texas
United States	Revival Research	Doral	Florida
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	The Pennsylvania Centre for Dermatology, LLC	Exton	Pennsylvania
United States	First OC Dermatology	Fountain Valley	California
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Austin Institute for Clinical Research - Dermatology	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	The Skin Wellness Center PC	Knoxville	Tennessee
United States	Dermatologists of Southwest Ohio	Mason	Ohio
United States	International Dermatology Research, Inc	Miami	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Epiphany Dermatology of Kansas, LLC	Overland Park	Kansas
United States	Alliance Dermatology and Mohs Center	Phoenix	Arizona
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	ActivMed Practices & Research, LLC.	Portsmouth	New Hampshire
United States	Progressive Clinical Research [Texas]	San Antonio	Texas
United States	University Clinical Trials, Inc.	San Diego	California
United States	San Luis Dermatology and Laser Clinic - Dermatology	San Luis Obispo	California
United States	Clinical Science Institute	Santa Monica	California
United States	Unison Clinical Trials	Sherman Oaks	California
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Springfield Clinic	Springfield	Illinois
United States	Acclaim Dermatology	Sugar Land	Texas
United States	Moore Clinical Research Inc.	Tampa	Florida
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI Percent Change From Baseline to Week 12	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. Higher scores represent worse symptom severity.	Baseline (Day 1 [Week 0]) and Week 12
Secondary	PASI Percent Change at Other Timepoints	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. Higher scores represent worse symptom severity.	Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (End of Study [EOS])
Secondary	Percentage of Participants With PASI 75 Response Throughout the Study	Reduction in disease was 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. Higher scores represent worse symptom severity.	Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)
Secondary	Percentage of Participants With PASI 100 Response Throughout the Study	Reduction in disease was 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. Higher scores represent worse symptom severity.	Baseline (Day 1 [Week 0]), Weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized FAS only), 44 (dose intensification only) and Week 52 (EOS)
Secondary	Percentage of Participants With sPGA Responses (0/1) at Week 12 and Week 52	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response was defined as a sPGA value of clear (score 0) or almost clear (score 1). Higher scores represent worse symptom severity.	Week 12 and Week 52 (EOS)
Secondary	Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52	The percentage of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represents roughly 1% of the body's surface.	Baseline (Day 1 [Week 0]), Week 12 and Week 52 (EOS)
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	TEAEs were summarized by actual treatment received. For each category, participants were included only once, even if they experienced multiple events in that category.	Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Secondary	Number of Participants With Events of Interests (EOIs)	The EOIs pre-specified 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, serious depression including suicidality, and venous thromboembolism.	Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)
Secondary	Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654	A participant was considered to have developed ADAs if they: had a positive post-baseline binding or neutralizing antibody result with a negative or no result at Baseline or; had a positive post-baseline binding or neutralizing antibody result with a negative or no result prior to the first dose in the post Week 28 study period.	Baseline; Day 1 (Week 0) to Week 28; Week 28 to Week 52 (EOS)

External Links

•   AmgenTrials clinical trials website