MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

NCT02660580 | Completed Phase 3 Results DMC

• 2 other identifiers: EMR200588-0022015-003287-37
• Study Type: interventional
• Target: 443
• Locations: 12 countries
• Sites: 76

Brief Summary

The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

Conditions

Psoriasis; Plaque Type Psoriasis; Moderate to Severe Plaque Psoriasis

Keywords

Adalimumab; MSB11022; Psoriasis; Phase III

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16

  PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.

  Week 16

Secondary Outcomes (37)

• Percent Change From Baseline in PASI at Week 16

  Baseline (Day 1 of Core Treatment Period), Week 16

• Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16

  Week 16

• Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24

  Week 24

• Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52

  Week 52

• Percent Change From Baseline in PASI at Week 24 and 52

  Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52

Study Arms (5)

MSB11022 (Core Treatment Period)

EXPERIMENTAL

Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Drug: MSB11022

EU-Humira

ACTIVE COMPARATOR

Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period.

Drug: Humira®

MSB11022 (Extended Treatment Period)

EXPERIMENTAL

Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Drug: MSB11022

EU-Humira/EU-Humira

ACTIVE COMPARATOR

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period.

Drug: Humira®

EU-Humira/MSB11022

EXPERIMENTAL

Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.

Drug: MSB11022; Drug: Humira®

Interventions

MSB11022 DRUG

Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.

EU-Humira/MSB11022; MSB11022 (Core Treatment Period); MSB11022 (Extended Treatment Period)

Humira® DRUG

Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

EU-Humira; EU-Humira/EU-Humira; EU-Humira/MSB11022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] score \>=3, and \>=10% of body surface area affected at Screening and Baseline \[Day 1 of Week 1\]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy
• Participants must not have received more than 1 biologic therapy

You may not qualify if:

• Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis
• Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration
• Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis \[TB\]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex

Sponsors & Collaborators

• Fresenius Kabi SwissBioSim GmbH: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (76)

San Luis Dermatology & Laser Clinic, Inc.

San Luis Obispo, California, 93405, United States

Location

Florida Academic Centers Research and Education

Coral Gables, Florida, 33134, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Modern Research Associates

Dallas, Texas, 75231-5945, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

DCC 'Sveti Georgi' EOOD

Haskovo, 6300, Bulgaria

Location

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800, Bulgaria

Location

DCC "Sv. Georgi", EOOD

Plovdiv, 4000, Bulgaria

Location

Diagnostic Consultative Center II - Sofia OOD

Sofia, 1040, Bulgaria

Location

MC "Robert Koch", EOOD

Sofia, 1407, Bulgaria

Location

Medical Center "Excelsior", OOD

Sofia, 1407, Bulgaria

Location

DCC "Alexandrovska", EOOD

Sofia, 1431, Bulgaria

Location

UMHAT "Alexandrovska" EAD

Sofia, 1431, Bulgaria

Location

Military Medical Academy - MHAT - Sofia

Sofia, 1606, Bulgaria

Location

MC "Synexus - Sofia", EOOD

Sofia, 1784, Bulgaria

Location

DCC 3 - Varna, EOOD

Varna, 9023, Bulgaria

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Dr. Lorne E. Albrecht, Inc.

Surrey, British Columbia, V3V 0C6, Canada

Location

Gupta, Aditya K. MD

London, Ontario, N5X 2P1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research

Mississauga, Ontario, L5H 1G9, Canada

Location

Dr Melinda Gooderham Medicine Professional Corporation

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Center

Richmond Hill, Ontario, L4C 9M7, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Ste-Foy, Quebec, G1V 4X7, Canada

Location

Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

Nemocnice Novy Jicin a.s.

Nový Jičín, 741 01, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Clintrial, s.r.o.

Prague, 100 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Dermatovenerologická klinika

Praha 8 - Liben, 180 81, Czechia

Location

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, 40113, Czechia

Location

Vahlberg & Pild OÜ

Tallinn, 10134, Estonia

Location

East Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

Clinical Research Centre

Tartu, 50106, Estonia

Location

Tartu University Hospital

Tartu, 50417, Estonia

Location

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes Maritimes, 06202, France

Location

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque

Bordeaux, Gironde, 33000, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Licca

Augsburg, Bavaria, 86179, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Bonn AoeR

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Praxis fuer Dermatologie und Venerologie

Dresden, Saxony, 01097, Germany

Location

Clinical Research Hamburg GmbH

Hamburg, 22143, Germany

Location

Ambrozia Gondozohaz Szolg. Nonprofit Kft.

Budapest, 1238, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6720, Hungary

Location

ALLERGO-DERM BAKOS Kft.

Szolnok, 5000, Hungary

Location

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Unidad de Investigacion de las Enfermedades Reumaticas

Cuauhtémoc, Mexico City, 06090, Mexico

Location

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, 54055, Mexico

Location

Köhler & Milstein Research S.A de C.V.

Mérida, Yucatán, 97000, Mexico

Location

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Mérida, Yucatán, 97070, Mexico

Location

Derma Norte del Bajio S.C.

Aguascalientes, 20127, Mexico

Location

Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

Elblag, 82-300, Poland

Location

Gdanskie Centrum Zdrowia Sp. z o.o.

Gdansk, 80-542, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-349, Poland

Location

Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

Krakow, 31-023, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, 90-242, Poland

Location

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

Lodz, 94-048, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

Lublin, 20-406, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, 60-773, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

Torun, 87-100, Poland

Location

SP Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, 50-368, Poland

Location

Centrum Medyczne ADAMAR

Wroclaw, 53-658, Poland

Location

SBEI HPE "Kazan State Medical University" of the MoH of the RF

Kazan', 420012, Russia

Location

LLC "Alliance Biomedical - Russian Group"

Saint Petersburg, 196191, Russia

Location

Clinic of skin and veneral diseases

Saratov, 410028, Russia

Location

SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF

Yaroslavl, 150000, Russia

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Eugenia Kunina, senior clinical development manager
• Organization: Fresenius Kabi SwissBioSim GmbH

clinical.development@fresenius-kabi.com

+41791093376

Study Officials

• Medical Responsible

  Fresenius Kabi Swiss BioSim GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2016
• First Posted: January 21, 2016
• Study Start: February 16, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 18, 2017
• Last Updated: December 27, 2023
• Results First Posted: February 19, 2019

Record last verified: 2023-12

Locations

BU (11); RU (4); GB (2); FR (4); DE (5); CZ (7); PL (12); CA (9); ES (4); US (6); HU (5); ME (7)