Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum

NCT07767864 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00029003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn more about an experimental drug bimekizumab that may be helpful for Pyoderma Gangrenosum (PG). Bimekizumab will be referred to as the study drug throughout this form. The investigators are hoping to find out if bimekizumab helps in healing PG wounds. The study drug is experimental. It has been approved by the FDA for use in adults with psoriatic conditions but not for Pyoderma Gangrenosum (PG).

Conditions

Pyoderma Gangrenosum

Keywords

PG; Pyoderma; Pyoderma Gangrenosum; Chronic wounds; Chronic ulcers; Non-healing ulcers; Wound

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that achieve a PGA score of ≤ 1 at week-24.

  Proportion of participants that achieve a PGA score of ≤ 1 at week-24.

  24 weeks

Secondary Outcomes (14)

• Proportion of Participants Achieving Complete Re-epithelialization of the Target Ulcer

  Baseline through Week 24

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Baseline through Week 36 (final safety follow-up)

• Impact of skin disease on quality of life

  By week 28

• Quality of life via Participant Global Assessment

  By week 28

• Quality of life via Participant Physical Function Assessment

  By week 28

Other Outcomes (2)

• Change From Baseline in Cytokine Gene Expression

  Baseline, Week 12, Week 24

• Presence and Quantity of Hyperechoic Oval Structures, Hair Tracts, and U-shaped Vessels on High-Frequency Ultrasound

  Baseline, Week 12, Week 24

Study Arms (1)

Bimekizumab

EXPERIMENTAL

Will receive study drug

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Participants will receive bimekizumab 320 mg administered subcutaneously every 2 weeks for the first 16 weeks, followed by 320 mg every 4 weeks through Week 24

Bimekizumab

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
• Have a diagnosis of at least one PG ulcer defined by the investigator on the basis of results from clinical and/or histological and/or laboratory assessments: Classic PG defined as deep ulceration with undermining violaceous borders and PARACELSUS score \>10. If multiple ulcers are present, the largest ulcer (defined by greatest surface area) will be designated the target ulcer and followed throughout the study.
• Subject has a minimum of 1 evaluable ulcer (4cm2 - 225cm2) at screening.
• Be a candidate for systemic therapy.
• Undergoing at least once a week wound care at home or at a wound care facility.
• Participants must be on a stable dose of prednisone of 20 mg/day for at least two weeks prior to first drug administration (baseline) and must follow the baseline Prednisone tapering algorithm.
• Subjects on existing immunosuppression and systemic therapies for managing underlying comorbidities associated with PG but are not intended to treat PG specifically will be included in trial and allowed to continue these medications while on trial. The comorbidity must be on a stable clinical course and clinical treatment must be stable for at least 1 month prior to screening. Dosage of medication used to treat underlying comorbidities will be documented at each visit.
• Males ages 18 and above must agree to not father a child or donate sperm while on study and for at least 12 weeks following last dose of the study drug. A subject who is a sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a reliable form of birth control and confirm that female partner(s) are using birth control, or remain abstinent.
• Females ages 18 and above must be either of non-childbearing potential or of childbearing potential who test negative for pregnancy at screening, agree to urine pregnancy testing before receiving study intervention administration and agree to use at least two reliable methods of birth control or remain abstinent during the study and for at least 12 weeks following the last dose of bimekizumab Female subjects must agree to not donate eggs while on study or for 12 weeks after the last dose of bimekizumab.
• Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
• Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Be willing to travel to site for all study visits, and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.
• Be willing to undergo perilesional and nonlesional skin biopsy at week 0 and week 24 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies (perilesional and nonlesional) at week 16. Refusal to give consent for any of the optional research samples does not exclude a participant from participation in the study.

You may not qualify if:

• Any drug treatment specifically for PG including but not limited to biologicals (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:
• weeks for any therapeutic agent directly targeted to IL-17 including, but not limited to, secukinumab, brodalumab, ixekizumab
• weeks for infliximab;
• weeks for adalimumab;
• weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
• weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).
• If not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.
• Intralesional corticosteroids within 4 weeks of screening.
• Individuals with active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.
• Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for rheumatoid arthritis), are allowed as combination therapy except for MTX and Leflunomide which are allowed individually but not in combination.
• Individuals will be screened for IBD using a calprotectin test at screening. Individuals with inflammatory bowel disease (IBD) will be excluded from study.
• Concurrent skin disease that is deemed to interfere with assessment of ulcer.
• Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.
• Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mm Hg.
• Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• UCB Pharma: collaborator

Study Sites (1)

Oregon Health & Science University, Department of Dermatology

Portland, Oregon, 97239, United States

Location

Related Publications (14)

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• Neutrophil migration in hidradenitis suppurativa. Br J Dermatol. 2023 Apr 20;188(5):e36. doi: 10.1093/bjd/ljad093. No abstract available.

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• Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905.

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• Ortega-Loayza AG, Nugent WH, Lucero OM, Washington SL, Nunley JR, Walsh SW. Dysregulation of inflammatory gene expression in lesional and nonlesional skin of patients with pyoderma gangrenosum. Br J Dermatol. 2018 Jan;178(1):e35-e36. doi: 10.1111/bjd.15837. Epub 2017 Dec 5. No abstract available.

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• Adams R, Maroof A, Baker T, Lawson ADG, Oliver R, Paveley R, Rapecki S, Shaw S, Vajjah P, West S, Griffiths M. Bimekizumab, a Novel Humanized IgG1 Antibody That Neutralizes Both IL-17A and IL-17F. Front Immunol. 2020 Aug 21;11:1894. doi: 10.3389/fimmu.2020.01894. eCollection 2020.

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• Ormerod AD, Thomas KS, Craig FE, Mitchell E, Greenlaw N, Norrie J, Mason JM, Walton S, Johnston GA, Williams HC; UK Dermatology Clinical Trials Network's STOP GAP Team. Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial. BMJ. 2015 Jun 12;350:h2958. doi: 10.1136/bmj.h2958.

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MeSH Terms

Conditions

Pyoderma Gangrenosum; Pyoderma; Wounds and Injuries

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Alexandra Shinde, MSc

CONTACT

971-442-1620; shindea@ohsu.edu

Chloe Vignola

CONTACT

503-418-9045; vignola@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-arm, open-label, interventional, collaborative study

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)