Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756336
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-01-21
Brief Title:
LTX-109 as Treatment for Hidradenitis Suppurativa
Sponsor:
Pharma Holdings AS
Organization:
Pharma Holdings AS
Study Overview
Official Title:
Proof of Concept Study on LTX-109 as Treatment for Hidradenitis Suppurativa
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An Open label Phase IIproof of concept-study to demonstrate if percutaneous application of LTX-109 in a gel vehicle is a safe treatment of Hidradenitis suppurativa and to identify clinical response to intervention as well to identify if covariates such as age disease duration smoking state and BMI influence patient reported measures
Detailed Description:
It is unclear whether bacterial colonization in hidradenitis suppurativaacne inversa HS comprises a primary cause triggering factor or secondary phenomenon of the disease pathogenesis Studies imply that aberrant immune responses play a role involving both the innate and adaptive immune system however the clinical picture of HS lesions appears reminiscent of bacterial infection eg due to intense inflammation and malodorous discharge Recent microbiological studies indicate certain bacterial species are associated with mature HS lesions It is demonstrated a significant high occurrence of large bacterial biofilms aggregates 50 μm in diameter in tunnels In total an array of studies point to a potential involvement of a specific microbiota in the pathogenesis of HS
The antimicrobial effect of LTX-109 can reduce or eradicate bacterial growth and thus also the inflammatory stimulus of hidradenitis The antiinflammatory effects of LTX-109 through inhibition of bacterial colonization or infection can prevent rupture and proliferation of follicular material in the dermis Hidradenitis in more advanced stages can be targeted with this investigational drug However it is not reasonable to expect that chronic longstanding inflammation and sinus formation will heal in six week of intervention Therefore patients with most severe activity Hurley stadium III or with widespread disease 5 palm units will not be included in the study
The investigator wishes to document whether LTX-109 is an effective compound on hidradenitis Evidence-based medical treatment of mild disease consists of topical antibiotics Clindamycin Systemic antibiotics Tetracycline is used for disease that is more widespread In other parts of Europe but not recommended in Norway due to the fear of over-usage of Rifampicin patients who fail to exhibit response to treatment or have a moderate-to-severe disease systemic Clindamycin 300 in combination with Rifampicin can be given
Patients failing to exhibit response to treatment options mentioned above or for moderate-to-severe disease biologic therapy Adalimumab can be administered
Interestingly Bacterial growth in HS patients has shown a high level of resistance to antibiotics including rifampicin clindamycin and tetracyclines cited as an empiric choice in HS therapeutic guidelines
Therefore other treatment options targeting bacteria in HS is warranted
It would be important to demonstrate whether the lytic peptidomimetic LTX-109 may be effective in the condition as the treatment has apparent benefits such as a good safety profile easy self-administered application and no known risk of development of resistance to the Investigational Medicinal Product
The study will be open label on 16 patients Treatment will be twice daily application on affected lesions for 6 weeks Followup after end of treatment will be 3 months
The antimicrobial effect of LTX-109 can reduce or eradicate bacterial growth and thus also the inflammatory stimulus of hidradenitis The antiinflammatory effects of LTX-109 through inhibition of bacterial colonization or infection can prevent rupture and proliferation of follicular material in the dermis Hidradenitis in more advanced stages can be targeted with this investigational drug However it is not reasonable to expect that chronic longstanding inflammation and sinus formation will heal in six week of intervention Therefore patients with most severe activity Hurley stadium III or with widespread disease 5 palm units will not be included in the study
The investigator wishes to document whether LTX-109 is an effective compound on hidradenitis Evidence-based medical treatment of mild disease consists of topical antibiotics Clindamycin Systemic antibiotics Tetracycline is used for disease that is more widespread In other parts of Europe but not recommended in Norway due to the fear of over-usage of Rifampicin patients who fail to exhibit response to treatment or have a moderate-to-severe disease systemic Clindamycin 300 in combination with Rifampicin can be given
Patients failing to exhibit response to treatment options mentioned above or for moderate-to-severe disease biologic therapy Adalimumab can be administered
Interestingly Bacterial growth in HS patients has shown a high level of resistance to antibiotics including rifampicin clindamycin and tetracyclines cited as an empiric choice in HS therapeutic guidelines
Therefore other treatment options targeting bacteria in HS is warranted
It would be important to demonstrate whether the lytic peptidomimetic LTX-109 may be effective in the condition as the treatment has apparent benefits such as a good safety profile easy self-administered application and no known risk of development of resistance to the Investigational Medicinal Product
The study will be open label on 16 patients Treatment will be twice daily application on affected lesions for 6 weeks Followup after end of treatment will be 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None