A Phase 1/2 interventional study of LTX-109 gel, 3% w/w in Hidradenitis Suppurativa, sponsored by Pharma Holdings AS. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Pharma Holdings AS · Phase 1/2, Interventional, and Treatment
An Open label Phase II//proof 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.
It is unclear whether bacterial colonization in hidradenitis suppurativa/acne 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, e.g. 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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Pharma Holdings AS is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:
Patients are treated with LTX-109 gel, 3% w/w twice daily (morning- evening) by application on active hidradenitis lesions during the intervention period of 6 weeks
Drug: LTX-109 gel, 3% w/w
The drug is applied to affected lesions according to treatment regimen
Investigator assessed signs for local reactions to the Investigational Medicinal Product
Investigator assessment of signs of local reactions
Time frame: End point analysis at 6 weeks
Patient reported symptoms for local reactions to the Investigational Medicinal Product
Patient reported symptoms for local reactions
Time frame: End point analysis at 6 weeks
Change in Investigator assessment of condition from Baseline
Investigator assessed change in condition assessed by Hidradenitis suppurativa score (Sartorius) from Baseline to week 6
Time frame: End point analysis after 6 weeks
Change in Investigator assessment disease activity from Baseline
Investigator assessed change in disease activity assessed by Hurley's stage division from Baseline to week 6
Time frame: End point analysis after 6 weeks
Change in Investigator assessed number of lesions from Baseline
Investigator assessed change in number of inflammatory lesions from Baseline to week 6 assessed by International Hidradenitis Suppurativa Severity Score System
Time frame: End point analysis after 6 weeks
Change in Patient recorded Dermatology Life Quality Index (DLQI) from Baseline
Change in patient recorded Dermatology Life Quality Index (DLQI) from Baseline to week 6
Time frame: Endpoint analysis at week 6
Change in Patient recorded Visual Analog Score for pain (VAS) from Baseline
Change in patient recorded Visual Analog Score for pain (VAS) from Baseline to week 6
Time frame: Endpoint analysis at week 6
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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