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

Sponsor
Amgen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04761627
Collaborator
(none)
494
Enrollment
94
Locations
2
Arms
23.9
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
494 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 24, 2021
Anticipated Primary Completion Date :
Mar 20, 2023
Anticipated Study Completion Date :
Mar 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Continued-use Group (Ustekinumab)

Participants will receive subcutaneous injection of ustekinumab up to Week 52.

Drug: Ustekinumab
Participants will receive subcutaneous (SC) injection of ustekinumab.
Other Names:
  • Stelara®

    		•
    Experimental: 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.

    Drug: Ustekinumab
    Participants will receive subcutaneous (SC) injection of ustekinumab.
    Other Names:
  • Stelara®

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

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Curve from Time 0 over the Dosing Interval (AUCtau) [Week 52 (pre-dose and post-dose) until Week 64]

      To evaluate AUCtau in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.

    2. Maximum Concentration (Cmax) [Week 52 (pre-dose and post-dose) until Week 64]

      To evaluate Cmax in participants with multiple switches between ustekinumab and ABP 654 compared to participants receiving continued use of ustekinumab.

    Secondary Outcome Measures

    1. Time of Maximum Concentration (tmax) [Week 52 (pre-dose and post-dose) until Week 64]

      To assess the tmax in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

    2. Trough Concentration at Steady State (Ctrough,ss) [Week 28 (pre-dose and post-dose) until Week 52 (pre-dose and post-dose)]

      To assess the Ctrough,ss in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

    3. Percent Improvement in PASI From Baseline to Week 64 [Baseline (Day 1) until Week 64]

      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.

    4. Percentage of Participants with PASI 75 Response at Week 64 [Week 64]

      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.

    5. Percentage of Participants with PASI 100 Response at Week 64 [Week 64]

      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.

    6. Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events [Week 28 until Week 64]

      To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

    7. Number of Participants With Events of Interest [Week 28 until Week 64]

      To assess the safety in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

    8. Number of Participants With Positive Anti-drug Antibodies to ABP 654 [Week 28 until Week 64 (Pre-dose)]

      To assess the immunogenicity in participants with multiple switches between ABP 654 and ustekinumab compared with participants receiving continued use of ustekinumab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Burke Pharmaceutical Research Hot Springs Arkansas United States 71913
    2 Zenith Research Inc. Beverly Hills California United States 90212
    3 Center for Dermatology Clinical Research, Inc. Fremont California United States 94538
    4 Quest Dermatology Research Northridge California United States 91324-4669
    5 Southern California Dermatology, Inc Santa Ana California United States 92701
    6 Clearlyderm Dermatology Boca Raton Florida United States 33428
    7 Encore Research Group-Jacksonville Center for Clinical Resea Jacksonville Florida United States 32216
    8 International Dermatology Research, Inc. Miami Florida United States 33144
    9 Altus Research, Inc. Palm Springs Florida United States 33461
    10 Riverchase Dermatology and Cosmetic Surgery Pembroke Pines Florida United States 33028-1013
    11 Olympian Clinical Research Tampa Florida United States 33614
    12 Hamilton Research, LLC Alpharetta Georgia United States 30022
    13 Advanced Medical Research PC Sandy Springs Georgia United States 30328
    14 Dundee Dermatology West Dundee Illinois United States 60118
    15 DS Research Clarksville Indiana United States 47129
    16 DS Research Corydon Indiana United States 47112-2174
    17 Integrated Clinical Trial Services Inc. West Des Moines Iowa United States 50265
    18 Kansas Medical Clinic, PA Topeka Kansas United States 66614
    19 Clinical Pharmacology Study Group Worcester Massachusetts United States 01605
    20 Hamzavi Dermatology Fort Gratiot Michigan United States 48059
    21 Minnesota Clinical Study Center New Brighton Minnesota United States 55112
    22 Skin Specialists PC Omaha Nebraska United States 68144
    23 ActivMed Practices & Research, LLC. Portsmouth New Hampshire United States 03801
    24 Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
    25 The Dermatology Group, PC Verona New Jersey United States 07044
    26 Buffalo Medical Group, PC Buffalo New York United States 14221
    27 OnSite Clinical Solutions, LLC Charlotte North Carolina United States 28209
    28 Wilmington Dermatology Center Wilmington North Carolina United States 28405
    29 Oregon Medical Research Center Portland Oregon United States 97223
    30 Austin Institute for Clinical Research, Inc. Dripping Springs Texas United States 78620
    31 Austin Institute for Clinical Research, Inc - Dermatology Pflugerville Texas United States 78660
    32 Stephen Miller, MD, PA San Antonio Texas United States 78249
    33 Center for Clinical Studies, LTD., LLP Webster Texas United States 77598
    34 Dermatology of Seattle Burien Washington United States 98168
    35 Dermatology Research Institute Calgary Alberta Canada T2J 7E1
    36 Enverus Medical Research Surrey British Columbia Canada V3V 0C6
    37 Dr. Irina Turchin PC Inc. Fredericton New Brunswick Canada E3B 1G9
    38 CCA Medical Research Ajax Ontario Canada L1S 7K8
    39 SimcoDerm Medical and Surgical Dermatology Center Barrie Ontario Canada L4M 7G1
    40 Guelph Dermatology Research Guelph Ontario Canada N1L 0B7
    41 Dr Wei Jing Loo Medicine Professional Corporation London Ontario Canada N6H 5L5
    42 Lynderm Research Inc Markham Ontario Canada L3P 1X3
    43 DermEdge Research Inc. Mississauga Ontario Canada L4Y 4C5
    44 Dr. S. K. Siddha Medicine Professional Corporation - Doctor's Office Newmarket Ontario Canada L3Y 5G8
    45 North York Research Inc. - Dermatology North York Ontario Canada M2M 4J5
    46 Dermatology Ottawa Research Centre Ottawa Ontario Canada K2C 3N2
    47 Research Toronto Toronto Ontario Canada M4W 2N4
    48 K. Papp Clinical Research Inc. Waterloo Ontario Canada N2J 1C4
    49 Skinsense Medical Research Saskatoon Saskatchewan Canada S7K 0H6
    50 Confido Private Medical Clinic - General Practice/Medicine Tallinn Harjumaa Estonia 10138
    51 Clinical Research Center Tartu Tartumaa Estonia 50106
    52 Innomedica OÜ Tallinn Estonia 10117
    53 Tartu University Hospital Tartu Estonia 50417
    54 Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine Tbilisi T'bilisi Georgia 0112
    55 LTD Aversi Clinic Tbilisi T'bilisi Georgia 0160
    56 LTD Israeli-Georgian Medical Research Clinic Helsicore Tbilisi Georgia 0112
    57 ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology LLC Tbilisi Georgia 0159
    58 ,,Tbilisi Cancer center"LTD Tbilisi Georgia 0159
    59 Derma-Study-Center-FN Friedrichshafen Baden-Württemberg Germany 88045
    60 Licca Clinical Research Institute Augsburg Bayern Germany 86179
    61 Dermatologische Gemeinschaftspraxis Dres.Scholz Sebastian Schilling Mahlow Brandenburg Germany 15831
    62 Universitätsklinikum Frankfurt am Main - Klinik für Dermatol Frankfurt/Main Hessen Germany 60590
    63 Fachklinik Bad Bentheim Bad Bentheim Niedersachsen Germany 48455
    64 Praxis Hoffmann Witten Nordrhein-Westfalen Germany 58453
    65 Klinische Forschung Dresden GmbH Dresden Sachsen Germany 01069
    66 Universitätsklinikum Carl Gustav Carus Dresden Sachsen Germany 01307
    67 UK-SH - Lübeck Lübeck Schleswig-Holstein Germany 23538
    68 Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie Berlin Germany 10117
    69 Rothhaar Studien GmbH Berlin Germany 10783
    70 Debreceni Egyetem Klinikai Központ Nagyerdei Campus Debrecen Hajdú-Bihar Hungary 4032
    71 Brgyógyászati és Allergológiai Magánrendelés Szolnok Jász-Nagykun-Szolnok Hungary 5000
    72 Qualiclinic Kft Budapest Pest Hungary 1036
    73 UNOMEDICALTRIALS Kft Budapest Pest Hungary 1135
    74 Derma-B Kft Debrecen Hungary 4031
    75 Riga 1st hospital, Clinic of Dermatology and STD Riga Rga Latvia LV1001
    76 J.Kisis LtD Riga Rga Latvia LV1003
    77 Smite Aija doctor practice in dermatology, venereology Talsi Latvia LV3201
    78 Centrum Medyczne ALL-MED Krakow Maopolskie Poland 30-033
    79 Centrum Medyczne Plejady Krakow Maopolskie Poland 30-363
    80 Medycyna Kliniczna Warszawa Mazowieckie Poland 00-874
    81 RENEW CLINIC Spolka Jawna Bialystok Poland 15-794
    82 Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz Poland 85-065
    83 Centrum Medyczne PRATIA Bydgoszcz Bydgoszcz Poland 85-796
    84 Centrum Medyczne Pratia Gdynia Gdynia Poland 81-338
    85 Krakowskie Centrum Medyczne Sp. z o.o. Krakow Poland 31-501
    86 Centrum Medyczne PROMED Krakow Poland 31-513
    87 Barbara Rewerska Diamond Clinic Krakow Poland 31-559
    88 ETG Siedlce Siedlce Poland 08-110
    89 RCMed Sochaczew Poland 96-500
    90 Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin Poland 71-434
    91 Centrum Medyczne Evimed Warszawa Poland 02-625
    92 DermMedica Sp. z o.o. Wroclaw Poland 51-318
    93 Hospital Universitario Reina Sofia Córdoba Andalucía Spain 14004
    94 Hospital Universitario 12 de Octubre Madrid Spain 28041

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT04761627
    Other Study ID Numbers:
    • 20200417
    • 2020-005205-42
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Psoriasis
    Biosimilar
    Psoriasis area and severity index
    Ustekinumab
    Skin Diseases
    Dermatologic Agents
    Papulosquamous
    Additional relevant MeSH terms:
    Psoriasis
    Ustekinumab

    Study Results

    No Results Posted as of Dec 15, 2021