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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


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
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