Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Plaque Psoriasis Psoriasis

Keywords

Moderate to severe chronic plaque psoriasisPsoriasis

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
+30 more secondary outcomes

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: M923Biological: Humira

Interventions

M923Biological

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

Also known as: Adalimumab

M923M923 and Humira

HumiraBiological

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Momenta Pharmaceuticals, Inc.
Industrylead

Study Sites (90)

Wallace Medical Group, Inc.

Beverly Hills, California, 90211, United States

Encino Research Center

Encino, California, 91436, United States

eStudySite

La Mesa, California, 91942, United States

eStudySite

Oceanside, California, 92056, United States

eStudySite

San Diego, California, 92120, United States

Shahram Jacobs MD, INC

Sherman Oaks, California, 91403, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteins

Results Point of Contact

Title: Jim Jin
Organization: Momenta

Study Officials

John Caminis, MD
Shire
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

572 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (35)

Study Arms (3)

M923

Humira

M923 and Humira

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (90)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (35)

Study Arms (3)

M923

Humira

M923 and Humira

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (90)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations