Phase 3 Clinical Trial for Spesolimab
October 1, 2026
What is the Clinical Trial About?
The clinical trial is a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate the safety and efficacy of spesolimab in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy. The trial objective is to evaluate the safety and efficacy of repeat dosing with Spesolimab versus placebo. The goal is to have complete closure of the target PG ulcer at any time up to Week 26.
STUDY DESIGN
Approximately 90 patients with ulcerative PG requiring systemic therapy.
Estimated study duration is approximately 1.5 years with IV dosing every 4 weeks.
KEY INCLUSION CRITERIA
• At least one measurable PG ulcer (≥5 cm²).
• Maximum duration of 6 months since diagnosis of target ulcer unless active and progressing.
KEY EXCLUSION CRITERIA
• Non-PG lesions or target PG ulcer >80 cm².
• Chronic noninflamed ulcers not responsive to immunosuppressive therapy.
• Active ulcer infection or significant bacterial, viral, fungal, or parasitic infection.
CONTACT INFORMATION
ClinicalTrials.gov Identifier: NCT06624670
Phone: 1-800-243-0127 (option 4)
Email: clintriage.rdg@boehringer-ingelheim.com
Clinical Trial Locations:
Birmingham AL, Phoenix AZ, Irvine CA, Miami FL, Tampa FL, Indianapolis IN, Ann Arbor MI, Fargo ND, Lebanon NH, New Hyde Park NY, Cleveland OH, Columbus OH, Dallas TX.
Patient concierge support through Scout Clinical.
Contact: 1-800-601-0012.