Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum

NCT04274166 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: IRB00063109Huang_IIT_CAIN457AUS24T
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to find out what effects (good and bad) secukinumab has on the subject and their pyoderma gangrenosum. Secukinumab is a type of medicine called human monoclonal antibodies. Monoclonal antibodies are proteins that recognize and attach to other specific proteins (in this case, immune system hormones called "cytokines") that your body produces. The cytokine (a "messenger" protein in the body) that secukinumab binds to and reduces the activity of is a naturally occurring cytokine called interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A may cause symptoms PG.

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (19)

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Screening visit

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Screening visit to Baseline visit.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Baseline visit to Week 2.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from week 2 to week 4.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 4 to week 8.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 8 to week 12.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 12 to week 16.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 16 to week 20.

• Efficacy - Investigator Global Assessment (IGA)

  Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 20 to week 24.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Baseline.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Baseline to week 2.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 2 to Week 4.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 4 to Week 8. .

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 8 to Week 12.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 12 to Week 16.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 16 to Week 20.

• Efficacy - Subject Global Assessment (SGA)

  Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

  Change from Week 20 to Week 24.

• Efficacy - Ulcer Lesion Assessment PG Target Lesion

  Number of subjects achieving 50% improvement in PG lesion size

  Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.

• Efficacy - Ulcer Lesion Assessment PG Target Lesion

  Number of subjects achieving resolution of inflammation with an erythema score of 0 and a border elevation of 0 on five point scales of none to very severe

  Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.

Study Arms (1)

Experimental

EXPERIMENTAL

2 s.c. secukinumab 150 mg injections

Drug: secukinumab 150 mg (2 injections per dose

Interventions

secukinumab 150 mg (2 injections per dose DRUG

secukinumab 150 mg (2 injections per dose

Also known as: secukinumab

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Must give written informed consent. 2. Has a diagnosis of pyoderma gangrenosum, as determined by the investigator based on the following diagnostic criteria4:
• a. Diagnosis requires both major criteria and at least two minor criteria i. Major criteria
• Rapid progression of a painful, necrolytic cutaneous ulcer with an irregular, violaceous, and undermined border
• Other causes of cutaneous ulceration have been excluded ii. Minor criteria
• \. History suggestive of pathergy or clinical finding of cribriform scarring 2. Systemic diseases associated with PG 3. Histopathologic findings (sterile dermal neutrophilia, ± mixed inflammation, ± lymphocytic vasculitis) 4. Treatment response (rapid response to systemic steroid treatment)
• \. PG global assessment of moderate to severe, with at least one ulcer measuring at least 3 cm in diameter.
• \. 18 years of age or greater. 5. Must require systemic therapy for their pyoderma gangrenosum, as determined by the investigator prior to Baseline. Currently prescribed low-dose corticosteroids (≤ 10 mg/day), and other medications within one week prior to investigational drug administration, may be continued with no change in dose or frequency during the study.

You may not qualify if:

• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
• Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
• Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
• Treatment with high dose (\>10 mg/day) systemic steroids (prednisone) within one week prior to investigational drug administration. Treatment with cyclosporine, thalidomide, methotrexate, mycophenolate mofetil, azathioprine, or other systemic immunosuppressant agents within the 14 days prior to investigational drug administration (requirement of a 2-week washout).
• Known HIV+, known viral hepatitis infection, known tuberculosis infection.
• Any subject with a current or history of a malignancy in the last five years (excluding treated basal cell carcinoma).
• Clinically significant abnormal laboratory measures at screening.
• Known Irritable Bowel Disease-associated PG

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Novartis: collaborator

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• William W Huang, MD. MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share