A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Double-Blind, Randomized,Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016482
• Other study ID #: M13-674
• Secondary ID: 2013-003275-36
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2013
• Last updated: May 4, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBelgium: Ethics CommitteeBelgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Paul-Ehrlich-InstitutAustralia: Human Research Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGreece: National Organization of MedicinesCanada: Institutional Review BoardFrance: Committee for the Protection of PersonnesGreece: Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to assess the safety and efficacy of adalimumab in subjects with nail psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult subjects with clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months) and at least 1 fingernail with nail psoriasis.

• Subject must have BSA = 10% and a target fingernail mNAPSI = 8 at Week 0, OR BSA = 5%, a target fingernail mNAPSI = 8 and a total mNAPSI score of = 20 at Week 0.

• Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain NRS score of >3.

• Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.

• Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.

• Target fingernail must have mNAPSI score of = 8.

• Adult subjects with clinical diagnosis of chronic.

Exclusion Criteria:

• Prior adalimumab therapy.

• Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.

• Recent infection requiring treatment.

• Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.

• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.

• History of cancer, except successfully treated skin cancer.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nail Psoriasis
• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Adalimumab (ADA)
Adalimumab (ADA)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 118075	Carlton
Australia	Site Reference ID/Investigator# 118076	Kogarah
Australia	Site Reference ID/Investigator# 116495	Phillip
Belgium	Site Reference ID/Investigator# 118096	Brussels
Belgium	Site Reference ID/Investigator# 122415	Brussels
Belgium	Site Reference ID/Investigator# 116515	Bruxelles
Belgium	Site Reference ID/Investigator# 116516	Ghent
Canada	Site Reference ID/Investigator# 117977	Markham
Canada	Site Reference ID/Investigator# 117980	Quebec
Canada	Site Reference ID/Investigator# 117978	St. John's
Canada	Site Reference ID/Investigator# 117979	Waterloo
France	Site Reference ID/Investigator# 120395	Bordeaux
France	Site Reference ID/Investigator# 116536	Poitiers
Germany	Site Reference ID/Investigator# 116636	Berlin
Germany	Site Reference ID/Investigator# 117983	Heidelberg
Germany	Site Reference ID/Investigator# 120777	Mainz
Greece	Site Reference ID/Investigator# 116640	Athens
Greece	Site Reference ID/Investigator# 116642	Athens
Greece	Site Reference ID/Investigator# 117985	Athens
Mexico	Site Reference ID/Investigator# 118863	Monterrey
Mexico	Site Reference ID/Investigator# 118865	Zapopan
Puerto Rico	Site Reference ID/Investigator# 116720	Carolina
United States	Site Reference ID/Investigator# 116741	Bakersfield	California
United States	Site Reference ID/Investigator# 116745	Birmingham	Alabama
United States	Site Reference ID/Investigator# 116753	Boston	Massachusetts
United States	Site Reference ID/Investigator# 116884	Burbank	California
United States	Site Reference ID/Investigator# 119597	East Windsor	New Jersey
United States	Site Reference ID/Investigator# 116797	Henderson	Nevada
United States	Site Reference ID/Investigator# 116759	La Jolla	California
United States	Site Reference ID/Investigator# 116772	Omaha	Nebraska
United States	Site Reference ID/Investigator# 116747	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 116771	Portland	Oregon
United States	Site Reference ID/Investigator# 134650	San Antonio	Texas
United States	Site Reference ID/Investigator# 116750	Tampa	Florida
United States	Site Reference ID/Investigator# 116767	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Greece,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of subjects achieving a total-fingernail mNAPSI 75 response	Proportion of subjects with a 75% improvement in mNAPSI score	From Week 0 to Week 26	No
Other	Proportion of subjects achieving PGA-F of "clear" or "minimal"	Physician's assessment of patient's fingernails that meet definition of clear or minimal.	From Week 0 to Week 26	No
Other	Proportion of subjects achieving "clear" or "minimal" in nail bed component of the PGA-F, among those with a nail bed component of "moderate" or worse.	Physician's assessment of patient's fingernails that meet definition of clear or minimal among those with a nail bed component of "moderate" for worse.	From Week 0 to Week 26	No
Other	Proportion of subjects achieving "clear" or "minimal" in nail matrix component of the PGA-F, among those with a nail matrix component of "moderate" or worse.	Physician's assessment of patient's fingernails that meet definition of clear or minimal among those with a nail matrix component of "moderate" or worse.	From Week 0 to Week 26	No
Other	Proportion of subjects achieving mNAPSI = 0 in target fingernail.		From Week 0 to Week 26	No
Other	Proportion of subjects achieving mNAPSI = 0 of all fingernails		From Week 0 to Week 26	No
Other	Proportion of subjects achieving mNAPSI = 2 of the target fingernail		From Week 0 to Week 26	No
Other	Proportion of subjects achieving mNAPSI = 2 of all fingernails		From Week 0 to Week 26	No
Other	Change in mNAPSI of the target fingernail		From Week 0 to Week 26	No
Other	Change in mNAPSI score of all fingernails		From Week 0 to Week 26	No
Other	Proportion of subjects achieving NAPSI=0 in all fingernails		From Week 0 to Week 26	No
Other	Proportion of subjects achieving NAPSI=0 in target fingernail		From Week 0 to Week 26	No
Other	Change in total NAPSI of of target fingernail		From Week 0 to Week 26	No
Other	Change in total NAPSI of all fingernails		From Week 0 to Week 26	No
Other	Change in Psoriasis Area Severity Index (PASI)		From Week 0 to Week 26	No
Other	Proportion of subjects achieving total PASI 75/50/90/100 among subjects with PASI score = 5		From Week 0 to Week 26	No
Other	Proportion of subjects achieving physician's global assessment of skin psoriasis (PGA-S) "clear" or "minimal"	Physician's assessment of patient's skin psoriasis that meets definition of clear or minimal	From Week 0 to Week 26	No
Other	Change in total body surface area (BSA)		From Week 0 to Week 26	No
Other	Change in Nail Psoriasis Pain Numeric Rating Scale (NRS)		From Week 0 to Week 26	No
Other	Change in Nail Psoriasis Physical Functioning Severity Score		From Week 0 to Week 26	No
Other	Change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL)		From Week 0 to Week 26	No
Other	Change in dermatology life quality index (DLQI)		From Week 0 to Week 26	No
Other	Proportion of subjects achieving DLQI of 0, and achieving DLQI of 0/1		From Week 0 to Week 26	No
Other	Change in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO)		From Week 0 to Week 26	No
Other	Change in EuroQol-5Dimensions-5Levels (EQ-5D-5L) Health Status Assessment		From Week 0 to Week 26	No
Other	Change in Hospital Anxiety Depression Scale (HADS)		From Week 0 to Week 26	No
Other	Proportion of subjects with a new diagnosis of psoriatic arthritis (PsA) during the study (with adverse event of PsA) among subjects without PsA.		From Week 0 to Week 26	No
Other	Change in Nail Psoriasis Quality of Life (Nail PsQoL)		From Week 0 to Week 26	No
Other	Percent change in mNAPSI of the target fingernail		From Week 0 to Week 26	No
Other	Percent change in mNAPSI score of all fingernails		From Week 0 to Week 26	No
Other	Percent change in total NAPSI of target fingernail		From Week 0 to Week 26	No
Other	Percent change in total NAPSI of all fingernails		From Week 0 to Week 26	No
Other	Percent change in Psoriasis Area Severity Index (PASI) of all fingernails		From Week 0 to Week 26	No
Other	Percent change in total body surface area (BSA)		From Week 0 to Week 26	No
Other	Percent change in Nail Psoriasis Pain Numeric Rating Scale (NRS)		From Week 0 to Week 26	No
Other	Percent change in Nail Psoriasis Physical Functioning Severity Score		From Week 0 to Week 26	No
Other	Percent change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL)		From Week 0 to Week 26	No
Other	Proportion of subjects achieving PGA-F of "clear"	Physician's assessment of patient's fingernails that meet definition of clear	From Week 0 to Week 26	No
Other	Proportion of subjects achieving PGA-S of "clear"	Physician's assessment of patient's skin psoriasis that meets definition of clear	From Week 0 to Week 26	No
Other	Proportion of subjects achieving 50% improvement in the scalp component of Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI)	Subjects with 50% improvement in the scalp component of the B-SNIPI among subjects with scalp score of 6 and greater at Week 0	From Week 0 to Week 26	No
Other	Proportion of subjects achieving 50% improvement in inverse psoriasis component of the B-SNIPI	Subjects achieving 50% improvement in inverse psoriasis component among subjects with inverse psoriasis score of 6 and greater at Week 0.	From Week 0 to Week 26	No
Primary	Proportion of subjects achieving a total-fingernail modified Nail Psoriasis Severity Index (mNAPSI) 75 response	Subjects achieving a 75% reduction in total mNAPSI of all fingernails	At Week 26	No
Primary	For US regulatory purposes: Proportion of subjects with a Physician's Global Assessment of Fingernails of "clear" or "minimal"	Physician's assessment of patient's fingernails that meet definition of clear or minimal.	At Week 26	No
Secondary	For Ex-US sites: Percent change in total mNAPSI of all fingernails		From Week 0 to Week 26	No
Secondary	For Ex-US: Proportion of subjects achieving mNAPSI = 0 in all fingernails	Subjects who achieve a mNAPSI score of 0	At Week 26	No
Secondary	For Ex-US: Change in Nail Psoriasis Pain Numeric Rating Scale (NRS)		From Week 0 to Week 26	No
Secondary	For Ex-US: Change in Nail Psoriasis Physical Functioning Severity Score		From Week 0 to Week 26	No
Secondary	For Ex-US: Proportion of subjects with at least 50% improvement in the scalp component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI)	Subjects with 50% improvement in the scalp component among subjects with scalp score of 6 or greater at Week 0	Week 0 to Week 26	No
Secondary	For Ex-US: Proportion of subjects achieving Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "minimal"		Week 0 to Week 26	No
Secondary	For US: Proportion of subjects achieving a total mNAPSI 75 response	Subjects with at least a 75% reduction in total mNAPSI of all fingernails.	Week 0 to Week 26	No
Secondary	For US: Percent change in total mNAPSI of all fingernails		Week 0 to Week 26	No
Secondary	For US: Proportion of subjects achieving mNAPSI = 0 in all fingernails	Proportion of subjects mNAPSI = 0	At Week 26	No
Secondary	For US: Change in Nail Psoriasis Pain Numeric Rating Scale (NRS)		Week 0 to Week 26	No
Secondary	For US: Change in Nail Psoriasis Physical Functioning Severity Score		Week 0 to Week 26	No
Secondary	For US: Proportion of subjects with at least 50% improvement in the scalp component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI)	Subjects with 50% improvement in the scalp component among subjects with scalp score of 6 or greater at Week 0	Week 0 to Week 26	No