Hidradenitis SuppurativaPhase 1/2NCT04756336
LTX-109 as Treatment for Hidradenitis Suppurativa
A Phase 1/2 study testing LTX-109 gel, 3% w/w in people with Hidradenitis Suppurativa, run by Pharma Holdings AS at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- LTX-109 gel, 3% w/w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 5 Mar 2021to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active hidradenitis in the stage I-II according to Hurley's classification.
- Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention.
- Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international guidelines, and national/local regulations.
- For women in fertile age: Concents to use highly effective contraception until the end of the study
Who cannot join
- Patients in need of emergency medical or surgical treatment of hidradenitis
- Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:
- Systemic therapy for HS, including but not limited to corticosteroids, antibiotics, dapsone or retinoids within 4 weeks
- Targeted biologic treatments (refer to within 5 half-lives [if known]) or within 12 weeks, whichever is longer.
- Topical treatments with antibiotics, including but not limited to clindamycin within 4 weeks
- Patients with hidradenitis affecting larger areas (>5 palm units)
Show all 9Show fewer
- Patient does not agree to be registered in the national quality register for HS
- Pregnant or lactating women
- Any reason why, in the opinion of the investigator, the patient should not participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Study on LTX-109 as Treatment for Hidradenitis Suppurativa
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.
Read the detailed description
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- LTX-109 gel, 3% w/w
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-109 gel, 3% w/wDrug
The drug is applied to affected lesions according to treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| LTX-109 treatment | Experimental | 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 Receives: Drug: LTX-109 gel, 3% w/w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessed signs for local reactions to the Investigational Medicinal Product
Investigator assessment of signs of local reactions
Measured: End point analysis at 6 weeks
Patient reported symptoms for local reactions to the Investigational Medicinal Product
Patient reported symptoms for local reactions
Measured: End point analysis at 6 weeks
Secondary outcomes (5)
Change in Investigator assessment of condition from Baseline
Investigator assessed change in condition assessed by Hidradenitis suppurativa score (Sartorius) from Baseline to week 6
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Endpoint analysis at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start5 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive case series
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Holdings AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Øystein Grimstad, Phd., MD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756336
- Sponsor's protocol ID
- C20-109-07
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study on LTX-109 as Treatment for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04756336
- Acronym / sponsor ID
- C20-109-07
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pharma Holdings ASIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital of North Norway
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 16 Feb 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive case series
| Arm | Type | Receives |
|---|---|---|
| LTX-109 treatment | Experimental | Drug: LTX-109 gel, 3% w/wPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with active hidradenitis in the stage I-II according to Hurley's classification.
- Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention.
- Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international guidelines, and national/local regulations.
- For women in fertile age: Concents to use highly effective contraception until the end of the study
Key exclusion criteria (9 listed)
- Patients in need of emergency medical or surgical treatment of hidradenitis
- Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:
- Patients with hidradenitis affecting larger areas (>5 palm units)
- Patient does not agree to be registered in the national quality register for HS
- Pregnant or lactating women
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 |
|---|---|---|
| LTX-109 gel, 3% w/wThe drug is applied to affected lesions according to treatment regimen | Drug | LTX-109 treatment |
Primary outcome
Investigator assessed signs for local reactions to the Investigational Medicinal Product
Time frame: End point analysis at 6 weeks
Investigator assessment of signs of local reactions
Patient reported symptoms for local reactions to the Investigational Medicinal Product
Time frame: End point analysis at 6 weeks
Patient reported symptoms for local reactions
5 secondary outcomes
Change in Investigator assessment of condition from Baseline
Time frame: End point analysis after 6 weeks
Change in Investigator assessment disease activity from Baseline
Time frame: End point analysis after 6 weeks
Change in Investigator assessed number of lesions from Baseline
Time frame: End point analysis after 6 weeks
Change in Patient recorded Dermatology Life Quality Index (DLQI) from Baseline
Time frame: Endpoint analysis at week 6
Change in Patient recorded Visual Analog Score for pain (VAS) from Baseline
Time frame: Endpoint analysis at week 6
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 30 Aug 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.
Øystein Grimstad, Phd., MD principal investigator
University Hospital of North Norway
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 LTX-109 gel, 3% w/w in people with Hidradenitis Suppurativa, run by Pharma Holdings AS at 1 site in Norway.
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 5 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 30 Aug 2021. 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 Norway. 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?
Investigator assessed signs for local reactions to the Investigational Medicinal Product (time frame: End point analysis at 6 weeks). The study lists 2 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 30 Aug 2021.