Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum (BEAT-PG)

A Single-arm Open-label Study Assessing Efficacy of Bimekizumab in Adult Participants With Pyoderma Gangrenosum Over 24 Weeks

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pyoderma Gangrenosum
• Intervention / Treatment: Drug: Bimekizumab

Detailed Description

This is a single-arm, open-label, interventional Phase 2 study evaluating the efficacy and safety of bimekizumab in adult participants with pyoderma gangrenosum (PG). Bimekizumab is a monoclonal antibody that inhibits IL-17A, IL-17F, and the IL-17AF heterodimer. It is FDA-approved for psoriatic conditions but is not currently approved for the treatment of PG.

Approximately 17 participants will be enrolled, with an anticipated 15 participants completing screening and initiating study treatment at Oregon Health & Science University (OHSU), accounting for an estimated 10% dropout rate.

Eligible 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. Participants will be trained to self-administer study drug at home following their initial in-clinic dose, with study staff available to monitor and support self-administration at subsequent visits. All participants will also be maintained on a standardized prednisone regimen, beginning at a stable dose of 20 mg/day for at least 2 weeks prior to baseline, followed by a protocol-specified tapering schedule.

Participants will attend a total of 14 in-person study visits over 36 weeks: Screening, Week 0 (baseline), and Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, and 36. Study procedures conducted across these visits include vital signs, physical examination, full-body skin examination, standardized wound care, target ulcer measurement and photography, patient-reported outcome questionnaires (including pain, physical function, and mental health screening), laboratory testing, wound fluid collection, high-frequency ultrasound imaging, and periodic skin biopsy (perilesional and nonlesional) at Weeks 0, 12, and 24.

Blood and tissue samples will also be collected for exploratory biomarker and genetic/genomic analyses, including gene expression profiling and, on an optional basis, whole genome sequencing, to characterize inflammatory pathways and potential genetic contributors to PG and treatment response.

The primary endpoint is the proportion of participants achieving a Physician's Global Assessment (PGA) score of ≤1 at Week 24. Secondary endpoints include the proportion of participants achieving complete healing of the target ulcer, improvement in patient-reported pain (Numeric Rating Scale), and other patient-reported outcome measures. Exploratory endpoints include characterization of systemic and cutaneous inflammatory cytokines and biomarkers associated with treatment response.

Participants will be followed for safety and disease status through Week 36, including a recurrence follow-up visit at Week 28 and a final safety follow-up visit at Week 36, approximately 12 weeks after completion of study drug dosing.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexandra Shinde, MSc; Phone Number: 971-442-1620; Email: shindea@ohsu.edu
• Study Contact Backup: Name: Chloe Vignola; Phone Number: 8-9045 503-418-9045; Email: vignola@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University, Department of Dermatology
      • Contact: Amanda Mundy; Phone Number: 503-494-6009; Email: mundya@ohsu.edu
      • Principal Investigator: Alex Ortega Loayza, MD, MCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

  1. 4 weeks for any therapeutic agent directly targeted to IL-17 including, but not limited to, secukinumab, brodalumab, ixekizumab
  2. 8 weeks for infliximab;
  3. 6 weeks for adalimumab;
  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
  5. 2 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.
• Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.
• Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.
• Participants with pyoderma gangrenosum with comorbid necrotizing ulcer features or disease will be excluded from study.

• Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities:

  1. Neutrophil count <1500 cells/µL
  2. Lymphocyte count <500 cells/µL
  3. Platelet count <100,000 cells/µL
  4. AST or ALT or alkaline phosphatase > 2 times the upper limit of normal
  5. Hemoglobin <10 g/dL
  6. Serum creatinine ≥1.5 mg/dL (SI: ≤137 μmol/L)
  7. White blood cells <3500 cells/ µL
• Participant has known allergies, hypersensitivity, or intolerance to bimekizumab or its excipients (refer to Investigator's brochure)
• Individuals who are pregnant, lactating or breastfeeding.
• History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.
• Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.

• Have signs or symptoms suggestive of active TB upon medical history and/or physical examination.

  1. Have had recent close contact with a person with active TB for which a physician specializing in TB has not ruled out latent TB or has not received appropriate treatment before the first study drug administration.
  2. Have a positive QuantiFERON®-TB Gold test result within 2 months before the first administration of study drug in which active TB has not been ruled out and for which appropriate treatment for latent TB has not been initiated before the first administration of study dug.
  3. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation. IGRA testing is not required at screening for participants with a history of treated latent TB or ongoing treatment for latent TB.
• Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.
• Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
• Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.
• History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).
• Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.
• Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Are investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling).
• Are currently enrolled in or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab; Will receive study drug	Drug: Bimekizumab; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Complete Re-epithelialization of the Target Ulcer	Complete re-epithelialization of the target ulcer, defined as full wound closure without drainage or dressing requirements, among participants who are candidates for systemic therapy.	Baseline through Week 24
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of participants with treatment-emergent adverse events, including serious adverse events, related and unrelated to bimekizumab.	Baseline through Week 36 (final safety follow-up)
Impact of skin disease on quality of life	A 3-item questionnaire assessing three domains of quality of life impact; symptoms, emotions, and function related to skin disease.	By week 28
Quality of life via Participant Global Assessment	Measures an individual's overall impression of their health, disease severity, or treatment response.	By week 28
Quality of life via Participant Physical Function Assessment	Evaluates an individual's ability to perform daily activities, mobility, strength, balance, and overall functional capacity.	By week 28
Patient Health Questionnaire-9	Measures the presence and severity of depressive symptoms over the past two weeks.	By week 28
Generalized Anxiety Disorder Assessment	Measures the severity of generalized anxiety disorder symptoms over the past two weeks.	By week 28
Change From Baseline in Average Pain Numeric Rating Scale (NRS) Score	Change from baseline in average pain over the preceding 7 days, rated on an 11-point NRS (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse pain.	Baseline through Week 24
Change From Baseline in Peak Pain Numeric Rating Scale (NRS) Score	Change from baseline in worst pain over the preceding 24 hours, rated on an 11-point NRS (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse pain.	Baseline through Week 24
Time to Complete Healing of the Target Ulcer	Time from baseline to first observation of complete re-epithelialization of the target ulcer without drainage or dressing requirements.	Baseline through Week 36
Time to Recurrence of Pyoderma Gangrenosum	Time from first observation of complete healing to first observation of PG recurrence at the target ulcer site or a new site.	Baseline through Week 36 (including the Week 28 recurrence follow-up visit)
Change From Baseline in Pro-inflammatory Cytokine and Chemokine Expression	Change from baseline in pro-inflammatory cytokine and chemokine expression measured in peripheral blood and lesional tissue.	Baseline, Week 12, Week 24
Change From Baseline in Lymphocyte and Neutrophil Migration Markers	Change from baseline in lymphocyte and neutrophil function and migration, assessed in peripheral blood and lesional tissue.	Baseline, Week 12, Week 24
Change From Baseline in Ulcer Tissue Remodeling by High-Frequency Ultrasound	Change from baseline in tissue remodeling characteristics at the target ulcer, assessed by high-frequency ultrasound imaging.	Baseline through Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Cytokine Gene Expression	Change from baseline in cytokine gene expression measured in skin and blood samples.	Baseline, Week 12, Week 24
Presence and Quantity of Hyperechoic Oval Structures, Hair Tracts, and U-shaped Vessels on High-Frequency Ultrasound	Presence and amount of hyperechoic oval structures, hair tracts, and U-shaped vessels identified at the target ulcer by high-frequency ultrasound imaging.	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: UCB Pharma

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• 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.
• Guenova E, Teske A, Fehrenbacher B, Hoerber S, Adamczyk A, Schaller M, Hoetzenecker W, Biedermann T. Interleukin 23 expression in pyoderma gangrenosum and targeted therapy with ustekinumab. Arch Dermatol. 2011 Oct;147(10):1203-5. doi: 10.1001/archdermatol.2011.168. Epub 2011 Jun 16.
• Langrish CL, Chen Y, Blumenschein WM, Mattson J, Basham B, Sedgwick JD, McClanahan T, Kastelein RA, Cua DJ. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005 Jan 17;201(2):233-40. doi: 10.1084/jem.20041257.
• Gaffen SL, Jain R, Garg AV, Cua DJ. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nat Rev Immunol. 2014 Sep;14(9):585-600. doi: 10.1038/nri3707.
• 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.
• Garg A, Malviya N, Strunk A, Wright S, Alavi A, Alhusayen R, Alikhan A, Daveluy SD, Delorme I, Goldfarb N, Gulliver W, Hamzavi I, Jaleel T, Kimball AB, Kirby JS, Kirchhof MG, Lester J, Lev-Tov H, Lowes MA, Micheletti R, Orenstein LA, Piguet V, Sayed C, Tan J, Naik HB. Comorbidity screening in hidradenitis suppurativa: Evidence-based recommendations from the US and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2022 May;86(5):1092-1101. doi: 10.1016/j.jaad.2021.01.059. Epub 2021 Jan 23.
• Neutrophil migration in hidradenitis suppurativa. Br J Dermatol. 2023 Apr 20;188(5):e36. doi: 10.1093/bjd/ljad093. No abstract available.
• Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 Jun 8;403(10443):2504-2519. doi: 10.1016/S0140-6736(24)00101-6. Epub 2024 May 22.
• 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.
• Ji YZ, Liu SR. Koebner phenomenon leading to the formation of new psoriatic lesions: evidences and mechanisms. Biosci Rep. 2019 Dec 20;39(12):BSR20193266. doi: 10.1042/BSR20193266.
• 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.
• Ortega-Loayza AG, Friedman MA, Reese AM, Liu Y, Greiling TM, Cassidy PB, Marzano AV, Gao L, Fei SS, Rosenbaum JT. Molecular and Cellular Characterization of Pyoderma Gangrenosum: Implications for the Use of Gene Expression. J Invest Dermatol. 2022 Apr;142(4):1217-1220.e14. doi: 10.1016/j.jid.2021.08.431. Epub 2021 Sep 15. No abstract available.
• McPhie ML, Kirchhof MG. Pyoderma gangrenosum treated with secukinumab: A case report. SAGE Open Med Case Rep. 2020 Jul 17;8:2050313X20940430. doi: 10.1177/2050313X20940430. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Wound; Chronic wounds; Chronic ulcers; PG; Pyoderma Gangrenosum; Pyoderma; Non-healing ulcers
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin Diseases, Vascular; Skin and Connective Tissue Diseases; Wounds and Injuries; Pyoderma; Pyoderma Gangrenosum; bimekizumab
• Other Study ID Numbers: STUDY00029003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No