Wound HealPhase 2NCT05608187

Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

A Phase 2 study testing ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2 and ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2 in people with Wound Heal and Wound Healing Disturbance of, run by Ilya Pharma at 2 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Heal, Wound Healing Disturbance of, Wound Healing Disorder
What is being tested?: ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2 and ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1 participants
Where: 2 sitesSweden
Study dates: 26 Sep 2022to 20 Dec 2024
Phase: Phase 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

Signed written informed consent
Males and females aged ≥18 years
Diagnosis of diabetes mellitus type 1 or 2
HbA1c ≤ 86 mmol/mol (≤ 10%) at Screening
Subjects with at least one first time or recurrent full thickness ulcer (at or below the ankle) which fulfils all of the following criteria at Screening and at the time of Baseline:
A non-interdigital wound

Show all 14Show fewer

Accessible for administration of IMP, wound study assessments and procedures
Persistence of the wound for at least 6 weeks at Baseline
Assessed by the investigator to be of non-venous etiology.
Minimum full skin ulcer without undermining, with no exposed muscle, tendon or bone
A wound area of 1.0 - 5.0 cm^2 after sharp or mechanical debridement at Screening
During the 2-weeks between start of Run-in Phase and Baseline the wound size must not decrease by more than 30% or increase by more than 25%, which correspond to wound areas of 0.7 - 6.3 cm^2, or at Screening expected by the Investigator to have a high probability for wound size changes within this range during this period.
Toe pressure ≥20 mm Hg
Expected to comply with the study procedures

Who cannot join

Infected index wound with clinical signs of inflammation at Screening or Baseline.
The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing
Wound duration longer than 2 years
Active Charcot deformity of the study foot
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
Hemoglobin concentration <100 g/L at Baseline

Show all 17Show fewer

Planned or ongoing treatment with corticosteroids to an equivalent dose of prednisolone >10 mg per day or other immunosuppressive therapy, or such treatment within 4 weeks prior to Baseline
Has any major surgery or hospitalization planned up to Week 26
Has changed a treatment for diabetes during the last 3 weeks before Baseline. Dose change is allowed
Ongoing treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors
Revascularization procedure in the index wound leg planned or undertaken within 8 weeks before Screening, or under investigation
Current smokers
Participation in other clinical studies or having received any investigational treatment within 1 month or at the earliest five times the half-life prior to Screening
Has any disease conditions, including ulcerative dermatological disorders and vasculitis, or comorbidities which is expected to prevent the subject from participating in the study or confounding the evaluation of the safety profile and effect on wound healing of ILP100
Pregnant or lactating woman
Male subjects not willing to use a condom and refrain from donating sperm
Female subjects of childbearing potential unless they use a contraceptive method with a failure rate of < 1% to prevent pregnancy

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

Department of Endocrinology, Skåne University Hospital
Lund, 221 85
Clinical Diabetes Research Unit at Uppsala University Hospital
Uppsala

Other trials in Sweden

About this study

Official title: A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year long-term follow-up period. A total of 30 subjects will be randomized to low dose of ILP100-Topical (ILP100Lo), high dose of ILP100-Topical (ILP100Hi) or Placebo according to a 1:1:1 randomization schedule.

The study will consist of a 3-weeks Screening and Run-in Phase, followed by a 5-week Treatment Phase starting from Baseline and an Assessment Phase from Week 5 to Week 26. Thereafter, the subjects will be followed yearly during 5 years in a Long-Term Safety Follow-up Phase.

Conditions: Wound Heal, Wound Healing Disturbance of, Wound Healing Disorder, Wound Healing Delayed, Diabetic Foot Ulcer, Diabetic Foot Ulcer Mixed
Being tested: ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2, ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2, Placebo
Keywords: emilimogene sigulactibac, ILP100, ILP100-Topical, Lactobacillus reuteri, Limosilactobacillus reuteri, CXCL12, diabetic foot ulcer, wound healing, Ilya Pharma, live biopharmaceutical product, lactic acid bacteria
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2Biological
Also called ILP100-Topical
Topical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 5x10^7 CFU/cm^2 wound area.
ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2Biological
Also called ILP100-Topical
Topical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 1x10^9 CFU/cm^2 wound area.
PlaceboBiological
Topical application of placebo (ILP100 dilution buffer mixed with the activation peptide SppIP).

Study groups in NCT05608187
Study group	Role	What they receive
ILP100Lo	Experimental	During the Treatment Phase, subjects will continue on standard of care according to the protocol and ILP100Lo (ILP100-Topical, 5x10^7 colony forming units (CFU)/cm^2) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31. Receives: Biological: ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2
ILP100Hi	Experimental	During the Treatment Phase, subjects will continue on standard of care according to the protocol and ILP100Hi (ILP100-Topical, 1x10^9 CFU/cm^2) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31. Receives: Biological: ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2
Placebo	Placebo comparator	During the Treatment Phase, subjects will continue on standard of care according to the protocol and Placebo (ILP100 dilution buffer mixed with the activation peptide SppIP) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare incidence of adverse events (AEs) between treatment groups
The incidence of AEs up to Week 26 will be presented for each treatment group and by category, causality, severity and frequency.
Measured: Compare between the ILP100-Topical and Placebo treatment arms up to Week 26.
Compare incidence of serious adverse events (SAEs) between treatment groups
The incidence of SAEs up to Week 26 will be presented for each treatment group and by category, causality, severity and frequency.
Measured: Compare between the ILP100-Topical and Placebo treatment arms up to Week 26.

Secondary outcomes (17)

Local tolerability by Investigator's assessment
Local tolerance to treatment will be assessed by the Investigator. Wound tolerability parameters will be presented in categories of appearance of inflammation, amount of exudate present, hemorrhage, presence of slough/necrotic tissue, presence of granulation tissue and hypergranulation.
Measured: Compare Investigator's local tolerability assessments up to Week 26 between the ILP100-Topical and Placebo treatment arms.
Local tolerability by Independent Assessor's assessment
Local tolerance to treatment will be assessed by the Independent Assessor. Wound tolerability parameters will be presented in categories of appearance of inflammation, amount of exudate present, hemorrhage, presence of slough/necrotic tissue, presence of granulation tissue and hypergranulation.
Measured: Compare local tolerability up to Week 26 between the ILP100-Topical and Placebo treatment arms.
Proportion of subjects with a local tolerability parameter Grade ≥ 2 per Investigator's Assessment
The proportion of subjects with a local tolerability parameter grade ≥ 2 will be calculated (grading system=0 to 3, where 3 is severe). Local tolerance to treatment, infection and wound healing will be assessed by the Investigator. Wound tolerability parameters include appearance of inflammation, amount of exudate present, hemorrhage, presence of slough/necrotic tissue, presence of granulation tissue and hypergranulation.
Measured: Compare the ILP100-Topical and Placebo treatment arms up to Week 26.
Proportion of subjects with a local tolerability parameter Grade ≥ 2 per Independent Assessor's Assessment
The proportion of subjects with a local tolerability parameter grade ≥ 2 will be calculated (grading system=0 to 3, where 3 is severe). Local tolerance to treatment, infection and wound healing will be assessed by the Independent Assessor. Wound tolerability parameters include appearance of inflammation, amount of exudate present, hemorrhage, presence of slough/necrotic tissue, presence of granulation tissue and hypergranulation.
Measured: Compare the ILP100-Topical and Placebo treatment arms up to Week 26.
Wound area reduction (percent of Baseline)
Wound area will be measured and calculated as proportion of the wound area at Baseline. Metric analyses of wound area is made on 3D models acquired up to Week 26.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Wound healing rate
Wound healing rate will be calculated as change in the wound area per week. Wound healing will be assessed by Investigators and Independent Assessor.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with ≥50% and 75% partially healed wounds
The proportion of subjects with ≥50% and 75% partially healed wounds will be calculated.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Time to partial (≥50% and 75%) and complete healing
Time to event outcomes will be evaluated using Kaplan-Meier curves. Wound healing is defined as full skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Wound healing will be assessed by Investigators and Independent Assessor.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Wound area
Wound area will be measured and calculated (cm^2). Metric analyses of wound healing, including area, are made using 3D models acquired Screening to Week 26. Wound measures will be automatically generated by a computer software and validated by the Independent Assessor.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with completely healed wounds
The proportion of subjects with completely healed wounds will be calculated. Wound healing is defined as full skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Wound healing will be assessed by Investigators and the Independent Assessor.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with recurrence of index wound
The proportion of subjects with recurrence of index wound will be calculated. For wound assessments after each index wound healing visit, it will be documented if the index wound is still healed or if any recurrence of the wound has occurred.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with new wound infections
The proportion of subjects with new wound infections will be calculated based on the Investigators evaluation of the skin, including assessing whether there are any new wound infections, at each study visit.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Days on antibiotic treatment
Days on antibiotic treatment as a percentage of days in the study up to Week 26 will be calculated for each subject.
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Change in subject-reported wound-related pain
Change in wound-related pain in the area of the index wound, as reported by subjects, using a numeric rating scale (NRS; 0-10, where 10 is the worst possible pain).
Measured: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Long-term incidence of AEs.
AEs and SAEs will be recorded during annual visits from Year 1 through Year 5.
Measured: Compare the ILP100-Topical and Placebo treatment arms up to Year 5 after initiation of treatment.
CXCL12 levels in plasma
CXCL12 levels in plasma as measured by enzyme-linked immunosorbent assay (ELISA).
Measured: Compare up to Week 16 between the ILP100-Topical and Placebo treatment arms.
Presence of viable L. reuteri containing the pSIP_CXCL12 plasmid in wounds
Bacteria will be collected from the wound and perilesional skin with sterile cotton swabs which will be cultured.
Measured: Compare up to Year 5 between the ILP100-Topical and Placebo treatment arms.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 202220 Dec 2024

First posted8 Nov 2022
Study start26 Sep 2022
Primary completion16 Dec 2024
Study completion20 Dec 2024

Why it stopped: Patient recruitment issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Wound HealStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05608187
Sponsor's protocol ID: IP-CT-003
Other IDs: 2021-000563-69
Status last verified: Mar 2025
First submitted: 3 Oct 2022
Last updated: 5 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Undecided due to ongoing development.

Publications

Vagesjo E, Ohnstedt E, Mortier A, Lofton H, Huss F, Proost P, Roos S, Phillipson M. Accelerated wound healing in mice by on-site production and delivery of CXCL12 by transformed lactic acid bacteria. Proc Natl Acad Sci U S A. 2018 Feb 20;115(8):1895-1900. doi: 10.1073/pnas.1716580115. Epub 2018 Feb 5.
PubMed 29432190
Ohnstedt E, Lofton Tomenius H, Vagesjo E, Phillipson M. The discovery and development of topical medicines for wound healing. Expert Opin Drug Discov. 2019 May;14(5):485-497. doi: 10.1080/17460441.2019.1588879. Epub 2019 Mar 14.
PubMed 30870037
Ohnstedt E, Lofton Tomenius H, Frank P, Roos S, Vagesjo E, Phillipson M. Accelerated Wound Healing in Minipigs by On-Site Production and Delivery of CXCL12 by Transformed Lactic Acid Bacteria. Pharmaceutics. 2022 Jan 19;14(2):229. doi: 10.3390/pharmaceutics14020229.
PubMed 35213962

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Wound Heal trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-controlled, Parallel, Exploratory Phase 2a Study to Evaluate Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT05608187
Acronym / sponsor ID: IP-CT-003
Conditions: Wound Heal, Wound Healing Disturbance of, Wound Healing Disorder, Wound Healing Delayed, Diabetic Foot Ulcer, Diabetic Foot Ulcer Mixed
Keywords: emilimogene sigulactibac, ILP100, ILP100-Topical, Lactobacillus reuteri, Limosilactobacillus reuteri, CXCL12, diabetic foot ulcer, wound healing
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patient recruitment issues
Enrolment: 1 participants (actual)
Lead sponsor: Ilya PharmaIndustry (pharma, biotech, devices)
Collaborators: European Commission
Study start: 26 Sep 2022 (actual)
Primary completion: 16 Dec 2024 (actual)
Study completion: 20 Dec 2024 (actual)
First posted: 8 Nov 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ILP100Lo	Experimental	Biological: ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2During the Treatment Phase, subjects will continue on standard of care according to the protocol and ILP100Lo (ILP100-Topical, 5x10^7 colony forming units (CFU)/cm^2) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31.
ILP100Hi	Experimental	Biological: ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2During the Treatment Phase, subjects will continue on standard of care according to the protocol and ILP100Hi (ILP100-Topical, 1x10^9 CFU/cm^2) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31.
Placebo	Placebo comparator	Biological: PlaceboDuring the Treatment Phase, subjects will continue on standard of care according to the protocol and Placebo (ILP100 dilution buffer mixed with the activation peptide SppIP) will be topically administered at two occasions on Day 1 (Baseline and Hour 2), Days 2, 3, and thereafter every second to third day until Day 31.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Signed written informed consent
Males and females aged ≥18 years
Diagnosis of diabetes mellitus type 1 or 2
HbA1c ≤ 86 mmol/mol (≤ 10%) at Screening
Subjects with at least one first time or recurrent full thickness ulcer (at or below the ankle) which fulfils all of the following criteria at Screening and at the time of Baseline:

Key exclusion criteria (17 listed)

Infected index wound with clinical signs of inflammation at Screening or Baseline.
The index wound determined as heavily exuding defined as requiring more than 1 dressing change per day or requiring use of super absorbent dressing
Wound duration longer than 2 years
Active Charcot deformity of the study foot
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2

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
ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2Also: ILP100-TopicalTopical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 5x10^7 CFU/cm^2 wound area.	Biological	ILP100Lo
ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2Also: ILP100-TopicalTopical application of ILP100-Topical (emilimogene sigulactibac) at a dose of 1x10^9 CFU/cm^2 wound area.	Biological	ILP100Hi
PlaceboTopical application of placebo (ILP100 dilution buffer mixed with the activation peptide SppIP).	Biological	Placebo

Primary outcome

Compare incidence of adverse events (AEs) between treatment groups
Time frame: Compare between the ILP100-Topical and Placebo treatment arms up to Week 26.
The incidence of AEs up to Week 26 will be presented for each treatment group and by category, causality, severity and frequency.
Compare incidence of serious adverse events (SAEs) between treatment groups
Time frame: Compare between the ILP100-Topical and Placebo treatment arms up to Week 26.
The incidence of SAEs up to Week 26 will be presented for each treatment group and by category, causality, severity and frequency.

17 secondary outcomes

Local tolerability by Investigator's assessment
Time frame: Compare Investigator's local tolerability assessments up to Week 26 between the ILP100-Topical and Placebo treatment arms.
Local tolerability by Independent Assessor's assessment
Time frame: Compare local tolerability up to Week 26 between the ILP100-Topical and Placebo treatment arms.
Proportion of subjects with a local tolerability parameter Grade ≥ 2 per Investigator's Assessment
Time frame: Compare the ILP100-Topical and Placebo treatment arms up to Week 26.
Proportion of subjects with a local tolerability parameter Grade ≥ 2 per Independent Assessor's Assessment
Time frame: Compare the ILP100-Topical and Placebo treatment arms up to Week 26.
Wound area reduction (percent of Baseline)
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Wound healing rate
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with ≥50% and 75% partially healed wounds
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Time to partial (≥50% and 75%) and complete healing
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Wound area
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with completely healed wounds
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with recurrence of index wound
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Proportion of subjects with new wound infections
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Days on antibiotic treatment
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Change in subject-reported wound-related pain
Time frame: Compare ILP100-Topical and Placebo treatment arms up to Week 26
Long-term incidence of AEs.
Time frame: Compare the ILP100-Topical and Placebo treatment arms up to Year 5 after initiation of treatment.
CXCL12 levels in plasma
Time frame: Compare up to Week 16 between the ILP100-Topical and Placebo treatment arms.
Presence of viable L. reuteri containing the pSIP_CXCL12 plasmid in wounds
Time frame: Compare up to Year 5 between the ILP100-Topical and Placebo treatment arms.

Results and safety

The study was stopped early (reason given: Patient recruitment issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Background: PubMed 29432190Vagesjo E, Ohnstedt E, Mortier A, Lofton H, Huss F, Proost P, Roos S, Phillipson M. Accelerated wound healing in mice by on-site production and delivery of CXCL12 by transformed lactic acid bacteria. Proc Natl Acad Sci U S A. 2018 Feb 20;115(8):1895-1900. doi: 10.1073/pnas.1716580115. Epub 2018 Feb 5.
Background: PubMed 30870037Ohnstedt E, Lofton Tomenius H, Vagesjo E, Phillipson M. The discovery and development of topical medicines for wound healing. Expert Opin Drug Discov. 2019 May;14(5):485-497. doi: 10.1080/17460441.2019.1588879. Epub 2019 Mar 14.
Background: PubMed 35213962Ohnstedt E, Lofton Tomenius H, Frank P, Roos S, Vagesjo E, Phillipson M. Accelerated Wound Healing in Minipigs by On-Site Production and Delivery of CXCL12 by Transformed Lactic Acid Bacteria. Pharmaceutics. 2022 Jan 19;14(2):229. doi: 10.3390/pharmaceutics14020229.
Individual participant dataSharing planned: Undecided. Undecided due to ongoing development.

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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.

Jan Apelqvist, MD/PhD principal investigator

Department of Endocrinology, Skåne University Hospital, Malmö, Sweden

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 Mar 2025. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?

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 was stopped early (reason given: Patient recruitment issues). Results are not available in the source record.

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?

Compare incidence of adverse events (AEs) between treatment groups (time frame: Compare between the ILP100-Topical and Placebo treatment arms up to Week 26.). 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?

On the ClinicalTrials.gov record for NCT05608187, which also lists 3 linked publications.

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 5 Mar 2025.