Pyoderma GangrenosumPhase 1/2NCT02733094
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
A Phase 1/2 study testing Secukinumab in people with Pyoderma Gangrenosum, run by Technical University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to 19 Sep 2019
- Phase
- Phase 1/2
- 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
- Confirmed diagnosis of Pyoderma gangrenosum
- Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location
- Characterization of target lesion (size, PGA, duration)
- 18-75 years of age
- Body weight ≥ 40 kg and ≤ 160 kg
- Signed informed consent
Who cannot join
- Permanent severe diseases, especially those affecting the immune system
- Pregnancy or breast feeding
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- Myocardial infarction or cardiac arrhythmia which requires drug therapy
- Evidence of severe renal dysfunction or significant hepatic disease
- History of irritable bowel disease
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- History of lymphoproliferative disorders
- Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Secukinumab
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32. Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Physician's global assessment
The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.
Measured: Week 16
Secondary outcomes (6)
Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
Measured: Week 2,3,8,16,28,40
Assessment of patient's quality of life
Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire.
Measured: Week 2, 4, 8, 16, 28, 40
Measurement of serum C reactive protein (mg/dl)
Measured: Week 2, 4, 8, 16, 28, 40
Measurement of leukocyte counts (x10.e3/µl)
Measured: Week 2, 4, 8, 16, 28, 40
Measurement of blood sedimentation rate (mm/h)
Measured: Week 2, 4, 8, 16, 28, 40
Immunohistochemical analysis of IL-17+ immune cells
The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion10 Sep 2019
- Study completion19 Sep 2019
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 Technical University of MunichThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Kilian Eyerich, MD, PhD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733094
- Sponsor's protocol ID
- CAIN547ADE01T
- Status last verified
- Feb 2020
- First submitted
- 28 Mar 2016
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT02733094
- Acronym / sponsor ID
- CAIN547ADE01T
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2016
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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 study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Drug: Secukinumab300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (9 listed)
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 | Drug | Open-label |
Primary outcome
Change of the Physician's global assessment
Time frame: Week 16
The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0.
6 secondary outcomes
Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²)
Time frame: Week 2,3,8,16,28,40
Assessment of patient's quality of life
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of serum C reactive protein (mg/dl)
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of leukocyte counts (x10.e3/µl)
Time frame: Week 2, 4, 8, 16, 28, 40
Measurement of blood sedimentation rate (mm/h)
Time frame: Week 2, 4, 8, 16, 28, 40
Immunohistochemical analysis of IL-17+ immune cells
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kilian Eyerich, MD, PhD principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Secukinumab in people with Pyoderma Gangrenosum, run by Technical University of Munich at 1 site in Germany.
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 6 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of the Physician's global assessment (time frame: Week 16). 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 12 Apr 2023.