Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis

NCT02581345 | Completed Phase 3 Results

• 1 other identifier: 911401
• Study Type: interventional
• Target: 572
• Locations: 9 countries
• Sites: 90

Brief Summary

The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.

Conditions

Chronic Plaque Psoriasis; Psoriasis

Keywords

Moderate to severe chronic plaque psoriasis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16

  The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.

  Baseline; Week 16

Secondary Outcomes (35)

• Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16

  Week 16

• Number of Participants Achieving PASI 50 Response at Week 16

  Baseline; Week 16

• Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)

  Baseline; Week 52

• Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)

  Baseline; Week 52

• Number of Participants Achieving PASI 90 Response at Week 16

  Baseline; Week 16

Study Arms (3)

M923

EXPERIMENTAL

Participants assigned to receive M923

Biological: M923

Humira

ACTIVE COMPARATOR

Participants assigned to receive Humira

Biological: Humira

M923 and Humira

OTHER

Participants assigned to receive M923 and Humira

Biological: M923; Biological: Humira

Interventions

M923 BIOLOGICAL

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Also known as: Adalimumab

M923; M923 and Humira

Humira BIOLOGICAL

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Also known as: Adalimumab

Humira; M923 and Humira

Eligibility Criteria

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

You may qualify if:

• Must be able to understand and communicate with the investigator and comply with the requirements of the study
• Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
• Stable plaque psoriasis
• History of receipt of or candidate for therapy.
• Moderate to severe psoriasis at screening and baseline
• Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
• Male participants of childbearing potential must employ a highly effective contraceptive measure
• Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating. Female participants must also agree to employ a highly effective contraceptive measure.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type
• Drug-induced psoriasis.
• Other skin conditions which would interfere with assessment of psoriasis
• Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
• Other inflammatory conditions other than psoriasis or psoriatic arthritis
• Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
• Laboratory abnormalities at screening deemed clinically significant by the investigator
• Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
• History of latex allergy
• History of or current signs or symptoms or diagnosis of a demyelinating disorder
• History of or current Class III or IV New York Heart Association congestive heart failure
• Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma

Sponsors & Collaborators

• Momenta Pharmaceuticals, Inc.: lead

Study Sites (90)

Wallace Medical Group, Inc.

Beverly Hills, California, 90211, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

eStudySite

Oceanside, California, 92056, United States

Location

eStudySite

San Diego, California, 92120, United States

Location

Shahram Jacobs MD, INC

Sherman Oaks, California, 91403, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Bioclinical Research Alliance; Inc

Miami, Florida, 33155, United States

Location

Sanitas Reasearch, LLC

Miami, Florida, 33155, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Radiant Research; Inc.

Overland Park, Kansas, 66210, United States

Location

Tufts Medical Center; Inc.

Boston, Massachusetts, 02111, United States

Location

Bay State Clinical Trials, Inc

Watertown, Massachusetts, 02472, United States

Location

eStudySite

Las Vegas, Nevada, 89109, United States

Location

Radiant Research; Inc.

Cincinnati, Ohio, 45249, United States

Location

Radiant Research, Inc.

Columbus, Ohio, 43212, United States

Location

Radiant Clinical Research

Anderson, South Carolina, 29621, United States

Location

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, 29644, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29650, United States

Location

Austin Institute for Clinical Research, LLC

Pflugerville, Texas, 78660, United States

Location

Clinical Trials of Texas; Inc.

San Antonio, Texas, 78229, United States

Location

National Clinical Research-Richmond, Inc

Richmond, Virginia, 23294, United States

Location

Medical Centre Asklepii, OOD

Dupnitsa, 2600, Bulgaria

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

Department of Dermatology and Venereology, Faculty of Medicine, UMHAT Alexandrovska

Sofia, 1431, Bulgaria

Location

Mediprobe Research Inc

London, Ontario, N5X 2P1, Canada

Location

SKDS Research Inc

Newmarket, Ontario, L3Y 5G8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Office of Dr. Michael Robern

Ottawa, Ontario, K2G 6E2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, K2G 6E2, Canada

Location

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, N7T 4X3, Canada

Location

K Papp Clinical Research Inc

Waterloo, Ontario, N2J 1C4, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1M 1B1, Canada

Location

Dr. David Gratton Dermatologue Inc.

Montreal, Quebec, H3H 1V4, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Ste-Foy, Quebec, G1V 4X7, Canada

Location

CCBR Czech Prague s.r.o

Prague, Czech Republic, 13000, Czechia

Location

Dermatologie - MUDr. HELENA KORANDOVA s.r.o.

Olomouc, Povel, 779 00, Czechia

Location

CCBR Czech Brno, s.r.o

Brno, 60200, Czechia

Location

CCBR Czech a.s

Pardubice, 530 02, Czechia

Location

Clintrial s.r.o

Prague, 100 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

MUDr. Jaroslav Dragon - Kozni ordinace

Ústí nad Labem, 400 10, Czechia

Location

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

Ústí nad Labem, 40113, Czechia

Location

Parnu Hospital

Pärnu, 80010, Estonia

Location

Vahlberg & Pild OU

Tallinn, 10134, Estonia

Location

East Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Medicum AS

Tallinn, 13619, Estonia

Location

Kliiniliste Uuringute Keskus (Clinical Research Centre)

Tartu, 50106, Estonia

Location

Tartu University Hospital; Dermatology Clinic

Tartu, 50417, Estonia

Location

Universitaetsklinikum Schleswig Holstein

Schleswig, Holstein, 23538, Germany

Location

Klinische Forschunq Schwerin GmbH

Dorf Mecklenburg, Vorpommern, 19055, Germany

Location

Praxis fuer Dermatologie und Venerologie

Dresden, 01097, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, 60590, Germany

Location

Clinical Research Hamburg

Hamburg, 22143, Germany

Location

Riga 1 st Hospital

Riga, 1001, Latvia

Location

Derma Clinic Riga Ltd

Riga, LV-1003, Latvia

Location

Health Centre 4

Riga, LV-1003, Latvia

Location

J. Kisis Ltd

Riga, LV-1003, Latvia

Location

Health Centre 4

Riga, LV-1013, Latvia

Location

Ventspils Outpatient Clinic

Ventspils, LV-3601, Latvia

Location

Medica Pro Familia Sp. z o.o. S.K.A.

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Poradnia Kardiologiczna Jaroslaw Jurowiecki

Gdansk, 80-286, Poland

Location

Medica Pro Familia Sp. z o. o. S.K.A. Oddzial w Gdyni

Gdynia, 81-338, Poland

Location

NZOZ POLIMEDICA FILIA KIELCE (Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA)

Kielce, 25-364, Poland

Location

Medica Pro Familia Sp. z o.o. SK.A.

Krakow, 30-002, 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

Centrum Medyczne Szpital Swietej Rodziny

Lodz, 90-302, Poland

Location

NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

Lodz, 94-048, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

Medicome sp.zoo

Oświęcim, 32-600, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, 60-773, Poland

Location

Ai Centrum Medyczne

Poznan, 61-113, Poland

Location

KO-MED Centra Kliniczne Pulawy

Puławy, 24-100, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Location

NZOZ Nasz Lekarz

Torun, 87-100, Poland

Location

MTZ Clinical Research Sp z o.o.

Warsaw, 02-106, Poland

Location

KO-MED Centra Kliniczne Zamosc

Zamość, 22-400, Poland

Location

Nzoz Polimedica

Zgierz, 95-100, Poland

Location

Pedi-Derma s.r.o.

Košice, Košice Region, 04011, Slovakia

Location

Derma therapy spol. s.r.o.

Bratislava, 851 01, Slovakia

Location

Nemocnica Kosice-Saca, a.s., 1.sukromna nemocnica

Košice, 04015, Slovakia

Location

Dema-beauty, s.r.o

Nitra, 949 01, Slovakia

Location

Sanare S.r.o

Svidník, 089 01, Slovakia

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: Jim Jin
• Organization: Momenta

jjin@momentapharma.com

+16173954905

Study Officials

• John Caminis, MD

  Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: September 1, 2015
• Primary Completion: April 4, 2017
• Study Completion: April 4, 2017
• Last Updated: October 17, 2018
• Results First Posted: September 12, 2018

Record last verified: 2018-10

Locations

ES (7); PL (19); CA (10); SL (5); BU (5); CZ (8); US (24); DE (6); LA (6)