Pyoderma GangrenosumPhase 2NCT04274166
Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
A Phase 2 study testing secukinumab 150 mg (2 injections per dose in people with Pyoderma Gangrenosum, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- secukinumab 150 mg (2 injections per dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Must give written informed consent. 2. Has a diagnosis of pyoderma gangrenosum, as determined by the investigator based on the following diagnostic criteria4:
- 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
- 1. 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)
- 3. PG global assessment of moderate to severe, with at least one ulcer measuring at least 3 cm in diameter.
- 4. 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.
Who cannot join
- 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.
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- 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
About this study
Official title: The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
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.
Read the detailed description
This is a prospective, single center, Phase IIa study of secukinumab in the treatment of subjects diagnosed with PG. Subjects will be evaluated at Screening, Baseline (week 0), Week 1, Week 2, Week 3, Week 4, and then every 4 weeks for 24 weeks. The total duration of treatment is up to 20 weeks. Subjects may be treated for shorter durations if the lesions clear prior to week 20. Subjects will have a follow-up visit at 24 weeks, or 4 weeks after the last dose of study drug. Subjects will also have standard of care wound dressings done at each visit. Subjects will be given 300 mg of secukinumab SQ at week 0, 1, 2, 3, and 4, followed by injections every 4 weeks, for up to 20 weeks. Subjects may receive a dose increase at week 16 (if there is not at least a 25% reduction in target lesion size) to 300 mg every 2 weeks.
- Complete Blood Count (CBC), Comprehensive Metabolic panel (CMP), C- reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Hepatitis panel, HIV test, Pregnancy test, and QuantiFERON gold TB test will be performed at screening. (Appendix 6)
- CBC, CMP, CRP, ESR will be performed at week 8 and week 20.
- Pain rating by Likert scale (A 10-point scale to rate the level of pain - Appendix 2), an Investigator Global Assessment (IGA) (Appendix 3), Subject Global Assessment (SGA) (Appendix 3), and Ulcer Lesion Assessment (Appendix 5) will be done at Screening, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
- Lesion photography will be done at Screening and all visits.
- Infection and adverse event assessments and concomitant medication assessments will be performed at each visit.
- Quality of life will be measured with the Dermatology Life Quality Index (DLQI) at Baseline and Week 20 (Appendix 4).
- Conditions
- Pyoderma Gangrenosum
- Being tested
- secukinumab 150 mg (2 injections per dose
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumab 150 mg (2 injections per doseDrug
Also called secukinumab
secukinumab 150 mg (2 injections per dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 2 s.c. secukinumab 150 mg injections Receives: Drug: secukinumab 150 mg (2 injections per dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Measured: Screening visit
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: Baseline.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: Change from Week 20 to Week 24.
Efficacy - Ulcer Lesion Assessment PG Target Lesion
Number of subjects achieving 50% improvement in PG lesion size
Measured: 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
Measured: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Contracting never completed, closed the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- William W Huang, MD. MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274166
- Sponsor's protocol ID
- IRB00063109
- Other IDs
- Huang_IIT_CAIN457AUS24T
- Status last verified
- May 2021
- First submitted
- 12 Feb 2020
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT04274166
- Acronym / sponsor ID
- IRB00063109
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contracting never completed, closed the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single center, Phase IIa study of secukinumab in the treatment of subjects diagnosed with PG. Subjects will be evaluated at Screening, Baseline (week 0), Week 1, Week 2, Week 3, Week 4, and then every 4 weeks for 24 weeks. The total duration of treatment is up to 20 weeks. Subjects may be treated for shorter durations if the lesions clear prior to week 20. Subjects will have a follow-up visit at 24 weeks, or 4 weeks after the last dose of study drug. Subjects will also have standard of care wound dressings done at each visit. Subjects will be given 300 mg of secukinumab SQ at week 0, 1, 2, 3, and 4, followed by injections every 4 weeks, for up to 20 weeks. Subjects may receive a dose increase at week 16 (if there is not at least a 25% reduction in target lesion size) to 300 mg every 2 weeks.
- Complete Blood Count (CBC), Comprehensive Metabolic panel (CMP), C- reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Hepatitis panel, HIV test, Pregnancy test, and QuantiFERON gold TB test will be performed at screening. (Appendix 6)
- CBC, CMP, CRP, ESR will be performed at week 8 and week 20.
- Pain rating by Likert scale (A 10-point scale to rate the level of pain - Appendix 2), an Investigator Global Assessment (IGA) (Appendix 3), Subject Global Assessment (SGA) (Appendix 3), and Ulcer Lesion Assessment (Appendix 5) will be done at Screening, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
- Lesion photography will be done at Screening and all visits.
- Infection and adverse event assessments and concomitant medication assessments will be performed at each visit.
- Quality of life will be measured with the Dermatology Life Quality Index (DLQI) at Baseline and Week 20 (Appendix 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: secukinumab 150 mg (2 injections per dose2 s.c. secukinumab 150 mg injections |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Must give written informed consent. 2. Has a diagnosis of pyoderma gangrenosum, as determined by the investigator based on the following diagnostic criteria4:
- 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
- 1. 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)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secukinumab 150 mg (2 injections per doseAlso: secukinumabsecukinumab 150 mg (2 injections per dose | Drug | Experimental |
Primary outcome
Efficacy - Investigator Global Assessment (IGA)
Time frame: Screening visit
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Screening visit to Baseline visit.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Baseline visit to Week 2.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from week 2 to week 4.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Week 4 to week 8.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Week 8 to week 12.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Week 12 to week 16.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Week 16 to week 20.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Investigator Global Assessment (IGA)
Time frame: Change from Week 20 to week 24.
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Baseline.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Baseline to week 2.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 2 to Week 4.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 4 to Week 8. .
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 8 to Week 12.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 12 to Week 16.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 16 to Week 20.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Subject Global Assessment (SGA)
Time frame: Change from Week 20 to Week 24.
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Efficacy - Ulcer Lesion Assessment PG Target Lesion
Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
Number of subjects achieving 50% improvement in PG lesion size
Efficacy - Ulcer Lesion Assessment PG Target Lesion
Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Huang, MD. MPH principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing secukinumab 150 mg (2 injections per dose in people with Pyoderma Gangrenosum, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Investigator Global Assessment (IGA) (time frame: Screening visit). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.