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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02016482
First received: December 16, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Nail Psoriasis
Plaque Psoriasis
Biological: Adalimumab (ADA)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Subjects With Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects achieving a total-fingernail modified Nail Psoriasis Severity Index (mNAPSI) 75 response [ Time Frame: At Week 26 ] [ Designated as safety issue: No ]
    Subjects achieving a 75% reduction in total mNAPSI of all fingernails

  • For US regulatory purposes: Proportion of subjects with a Physician's Global Assessment of Fingernails of "clear" or "minimal" [ Time Frame: At Week 26 ] [ Designated as safety issue: No ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal.


Secondary Outcome Measures:
  • For Ex-US sites: Percent change in total mNAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • For Ex-US: Proportion of subjects achieving mNAPSI = 0 in all fingernails [ Time Frame: At Week 26 ] [ Designated as safety issue: No ]
    Subjects who achieve a mNAPSI score of 0

  • For Ex-US: Change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • For Ex-US: Change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Subjects with 50% improvement in the scalp component among subjects with scalp score of 6 or greater at Week 0

  • For Ex-US: Proportion of subjects achieving Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "minimal" [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • For US: Proportion of subjects acheiving a total mNAPSI 75 response [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Subjects with at least a 75% reduction in total mNAPSI of all fingernails.

  • For US: Percent change in total mNAPSI of all fingernails [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • For US: Proportion of subjects achieving mNAPSI = 0 in all fingernails [ Time Frame: At Week 26 ] [ Designated as safety issue: No ]
    Proportion of subjects mNAPSI = 0

  • For US: Change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • For US: Change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Subjects with 50% improvement in the scalp component among subjects with scalp score of 6 or greater at Week 0


Other Outcome Measures:
  • Proportion of subjects achieving a total-fingernail mNAPSI 75 response [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Proportion of subjects with a 75% improvement in mNAPSI score

  • Proportion of subjects achieving PGA-F of "clear" or "minimal" [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal.

  • 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. [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    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.

  • 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. [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    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.

  • Proportion of subjects achieving mNAPSI = 0 in target fingernail. [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving mNAPSI = 0 of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving mNAPSI ≤ 2 of the target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving mNAPSI ≤ 2 of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in mNAPSI of the target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in mNAPSI score of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving NAPSI=0 in all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving NAPSI=0 in target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in total NAPSI of of target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in total NAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Psoriasis Area Severity Index (PASI) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving total PASI 75/50/90/100 among subjects with PASI score ≥ 5 [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving physician's global assessment of skin psoriasis (PGA-S) "clear" or "minimal" [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Physician's assessment of patient's skin psoriasis that meets definition of clear or minimal

  • Change in total body surface area (BSA) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in dermatology life quality index (DLQI) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving DLQI of 0, and achieving DLQI of 0/1 [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in EuroQol-5Dimensions-5Levels (EQ-5D-5L) Health Status Assessment [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Hospital Anxiety Depression Scale (HADS) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a new diagnosis of psoriatic arthritis (PsA) during the study (with adverse event of PsA) among subjects without PsA. [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Change in Nail Psoriasis Quality of Life (Nail PsQoL) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in mNAPSI of the target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in mNAPSI score of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in total NAPSI of target fingernail [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in total NAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in Psoriasis Area Severity Index (PASI) of all fingernails [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in total body surface area (BSA) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Percent change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects acheiving PGA-F of "clear" [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Physician's assessment of patient's fingernails that meet definition of clear

  • Proportion of subjects acheiving PGA-S of "clear" [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Physician's assessment of patient's skin psoriasis that meets definition of clear

  • Proportion of subjects achieving 50% improvement in the scalp component of Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Subjects with 50% improvement in the scalp component of the B-SNIPI among subjects with scalp score of 6 and greater at Week 0

  • Proportion of subjects acheiving 50% improvement in inverse psoriasis component of the B-SNIPI [ Time Frame: From Week 0 to Week 26 ] [ Designated as safety issue: No ]
    Subjects achieving 50% improvement in inverse psoriasis component among subjects with inverse psoriasis score of 6 and greater at Week 0.


Estimated Enrollment: 200
Study Start Date: January 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab (ADA)
Adalimumab (ADA) sc eow (subcutaneous every other week) starting 1 week after initial loading dose
Biological: Adalimumab (ADA)
Adalimumab (ADA)
Placebo Comparator: Placebo (PBO) Arm
Placebo (PBO) Arm: Matching Placebo
Biological: Adalimumab (ADA)
Adalimumab (ADA)
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016482

Contacts
Contact: Sarah K Maddux, BS 847-937-2178 sarah.maddux@abbvie.com
Contact: La'Cheir S Hopkins, BS 847-935-6434 lacheir.hopkins@abbvie.com

  Show 33 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Dawn M Carlson, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02016482     History of Changes
Other Study ID Numbers: M13-674, 2013-003275-36
Study First Received: December 16, 2013
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Ethics Committee
Germany: Paul-Ehrlich-Institut
Australia: Human Research Ethics Committee
France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Greece: National Organization of Medicines
Canada: Institutional Review Board
United States: Institutional Review Board
Greece: Ethics Committee

Keywords provided by AbbVie:
Plaque Psoriasis
Nail Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014