PyodermaEarly Phase 1NCT04895566
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
A Early Phase 1 study testing Monoclonal antibody (Mab) sB24M in people with Pyoderma and Pyoderma Gangrenosum, run by SWISS BIOPHARMA MED GmbH at 2 sites in 2 countries.
Trial summary
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas. Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans
- What is being tested?
- Monoclonal antibody (Mab) sB24M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 May 2021to 16 Mar 2023
- Phase
- Early Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed
- Male or female, age ≥ 21 years
- Previous treatment with TNF antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy
- Secondary treatment failure with up to one previous TNFα antagonist treatment (from the list above)
- Secondary failure of corticosteroid treatment
- Adequate hematologic, hepatic, and renal function
- Written informed consent.
Who cannot join
- History of primary resistance or intolerance to any TNFα antagonist.
- History of congestive heart failure or current, controlled or uncontrolled
- Women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial
- Men, if no effective contraceptive method was used during the study and for 3 months afterward
- Any prior exposure to Hu5F9-G4 or other CD47 targeting agents
- Previous allogeneic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or need for graft-associated immunosuppression
- Refusal to sign the informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
Read the detailed description
This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
- Conditions
- Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans, Pyoderma Gangrenosum Surrounding Surgical Stoma
- Being tested
- Monoclonal antibody (Mab) sB24M
- Medical subject headings
- Pyoderma, Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal antibody (Mab) sB24MBiological
Also called CD47 / TNF-α Monoclonal antibody
200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.
| Study group | Role | What they receive |
|---|---|---|
| monoclonal antibody (Mab) sB24M | Experimental | Therapy by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma Receives: Biological: Monoclonal antibody (Mab) sB24M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) in patients with severe pyoderma
The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1
Measured: Approximately 1 year
Secondary outcomes (1)
Duration of response (DoR) of patients with severe forms of pyoderma
The DoR is defined as the time from the first registration of the onset of visible epithelialization of damaged tissues to the first recorded progression of pyoderma
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start24 May 2021
- Primary completion10 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyodermaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWISS BIOPHARMA MED GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895566
- Sponsor's protocol ID
- SBPM0311m
- Status last verified
- Mar 2023
- First submitted
- 17 May 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma
- ClinicalTrials.gov ID
- NCT04895566
- Acronym / sponsor ID
- SBPM0311m
- Conditions
- Pyoderma, Pyoderma Gangrenosum, Pyoderma Vegetans, Pyoderma Gangrenosum Surrounding Surgical Stoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SWISS BIOPHARMA MED GmbHUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 20 May 2021 (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.
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
Detailed description
This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monoclonal antibody (Mab) sB24M | Experimental | Biological: Monoclonal antibody (Mab) sB24MTherapy by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed
- Male or female, age ≥ 21 years
- Previous treatment with TNF antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy
- Secondary treatment failure with up to one previous TNFα antagonist treatment (from the list above)
- Secondary failure of corticosteroid treatment
Key exclusion criteria (7 listed)
- History of primary resistance or intolerance to any TNFα antagonist.
- History of congestive heart failure or current, controlled or uncontrolled
- Women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial
- Men, if no effective contraceptive method was used during the study and for 3 months afterward
- Any prior exposure to Hu5F9-G4 or other CD47 targeting agents
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 |
|---|---|---|
| Monoclonal antibody (Mab) sB24MAlso: CD47 / TNF-α Monoclonal antibody200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas. | Biological | monoclonal antibody (Mab) sB24M |
Primary outcome
Objective response rate (ORR) in patients with severe pyoderma
Time frame: Approximately 1 year
The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1
1 secondary outcome
Duration of response (DoR) of patients with severe forms of pyoderma
Time frame: Approximately 1 year
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 20 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Monoclonal antibody (Mab) sB24M in people with Pyoderma and Pyoderma Gangrenosum, run by SWISS BIOPHARMA MED GmbH at 2 sites in 2 countries.
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 7 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 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belarus, Latvia. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Objective response rate (ORR) in patients with severe pyoderma (time frame: Approximately 1 year). 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 20 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.