Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02315417
Other study ID # X052172
Secondary ID
Status Terminated
Phase Phase 3
First received December 5, 2014
Last updated April 25, 2016
Start date November 2014
Est. completion date March 2016

Study information

Verified date April 2016
Source XOMA (US) LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).


Other known NCT identifiers
  • NCT02366260

Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- A clinical diagnosis of classic pyoderma gangrenosum

- An active pyoderma gangrenosum ulcer

- Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

- Clinical evidence of acutely infected pyoderma gangrenosum

- History of allergic or anaphylactic reactions to monoclonal antibodies

- History of recurrent or chronic systemic infections

- Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
gevokizumab

Placebo

gevokizumab open-label


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment Day 126 No
Secondary The proportions of subjects at Day 126 with a reduction in the target ulcer area of = 75% or = 90% from baseline. Day 126 No
See also
  Status Clinical Trial Phase
Recruiting NCT06092216 - Spesolimab in Pyoderma Gangrenosum Phase 2
Completed NCT03311464 - A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan Phase 3
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Completed NCT00791557 - Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease N/A
Terminated NCT02318914 - A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum Phase 3
Completed NCT03137160 - An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum Phase 2
Not yet recruiting NCT05984654 - Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum N/A
Completed NCT04895566 - Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma Early Phase 1
Withdrawn NCT04274166 - Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum Phase 2
Completed NCT01882504 - Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum Phase 2
Withdrawn NCT00730717 - Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum Phase 2
Completed NCT03971643 - Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum Phase 2
Not yet recruiting NCT04792957 - JAK-STAT Signaling Pathway in Pyoderma Gangrenosum
Not yet recruiting NCT05821374 - Deucravacitinib in PG Early Phase 1
Terminated NCT03072953 - Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum Phase 2
Recruiting NCT05120726 - A Novel Therapeutic Treatment of Pyoderma Gangrenosum Phase 4
Withdrawn NCT00690846 - Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum Phase 2
Completed NCT01965613 - A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum Phase 2
Recruiting NCT01952275 - Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases N/A
Completed NCT01302795 - Canakinumab for Pyoderma Gangrenosum Phase 2