Epidermolysis Bullosa (EB)Phase 2STEPNCT06594393
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
A Phase 2 study testing TCP-25 gel in people with Epidermolysis Bullosa (EB) and Dystrophic Epidermolysis Bullosa, run by Xinnate AB at 13 sites in 7 countries.
Trial summary
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- What is being tested?
- TCP-25 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 30 Jan 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping.
- Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.
Who cannot join
- The patient has any subtype of EB other than DEB or JEB.
- The patient is currently being treated or planned to be treated with systemic antibiotics.
- Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.
- Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.
- Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
- The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
Spain3 sites, 3 recruiting
- Recruiting
San Joan de Deu, SJD Children's hospital Barcelona
Barcelona, Catalonia
Vicente Villa, MD
- Recruiting
Hospital Clinic de Barcelona
Barcelona
Riera Monroig, MD, JRIERA@clinic.cat
- Recruiting
Hospital Univ La Paz
Madrid
Greece2 sites, 2 recruiting
- Recruiting
Andreas Syngros Hospital of Veneral & Dermatological Diseases
Athens
- Recruiting
Hospital Of Skin And Venereal Diseases of Thessaloniki
Thessaloniki
Dimitra Kiritisi
Italy2 sites, 2 recruiting
- Recruiting
Hospital
Modena
Cristina Magnoni, Prof.
- Recruiting
IDI Istituto Dermopatico dell'Immacolata IRCCS
Rome
Dr. Didona, MD
Poland2 sites, 2 recruiting
- Recruiting
University hospital
Gdansk
Roman Nowicki, MD
Hanna Umer, MD
- Recruiting
Dermoklinika Centrum Medyczne
Lodz
Malgorzata Klys, RN, +48698141595, badaniakliniczne@dermoklinika.pl
Aleksandra Lesiak, MD
Sweden2 sites, 2 recruiting
- Not yet recruiting
University hospital
Lund, Skåne County, 23735
Emma Belfrage Sub-investigator, 46 46 17 100, info@regionskane.se
emmga.belfrage@skane.se
- Recruiting
Akademiska sjukhuset
Uppsala
Katja Holmgren, MD
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Dr. Kalyani Marathe, PI, MD, kalyani.marathe@cchmc.org
Bret Augsburger, RN, bret.augsburger@cchmc.org
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.
Read the detailed description
The study will include a Screening Period, a Treatment Period (Days 1 to 56, with study visits conducted every 2 weeks, including the baseline [Day 1], Day 14, Day 28, Day 42, and Day 56 visits) and a Safety Follow-up conducted via a telephone/video call at approximately 14 days after the last dose of the IMP. Patients will undergo efficacy, safety, tolerability, and PK assessments at scheduled visits. For evaluation of the primary efficacy endpoint, a trained clinician will take the images of the index wounds at all scheduled visits from baseline through Day 56 (Visit 6) using 3D digital photography and software for wound measurement.
- Conditions
- Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Being tested
- TCP-25 gel, Vehicle (placebo)
- Keywords
- epidermolysis bullosa, topical treatment
- Medical subject headings
- Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCP-25 gelDrug
Topical gel
Vehicle (placebo)Drug
Placebo gel
| Study group | Role | What they receive |
|---|---|---|
| TCP-25 | Experimental | Topical gel Receives: Drug: TCP-25 gel |
| Vehicle | Placebo comparator | Placebo gel Receives: Drug: Vehicle (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open wound area
Measured: 56 days
Secondary outcomes (8)
Frequency, intensity, and seriousness of Adverse Events in all treated patients until end of treatment
Measured: 56 days
Change in procedural pain using the Wong Baker FACES® Pain Rating Scale (0 min -10 max)
Wong Baker FACES pain rating scale uses 6 graphically or cartoon-depicted faces with varying facial expressions that represent no pain (no hurt) (Face 0) to worst pain/hurt that can be imagined (Face 10).
Measured: 56 days
Change from baseline in clinical impression of overall treatment area
Measured: 56 days
TCP-25 plasma concentrations
Measured: 56 days
Number of participants with treatment-related local tolerability assessment at the area of IMP application assessed on a 4-point scale
Measured: 56 days
Clinically significant changes from baseline in blood pressure until end of treatment
Measured: 56 days
Number of patients with clinically significant changes from baseline in pulse rate until end of treatment
Measured: 56 days
Number of patients with clinically significant changes from baseline in physical examination findings until end of treatment
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis Bullosa (EB)Studies 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
- Model description
- Intra-subject control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinnate AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594393
- Sponsor's protocol ID
- TCP25-002
- Acronym
- STEP
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wallblom K, Holmgren K, Lundgren S, Belfrage E, Hoppe T, Hugerth M, Lindqvist AK, Sonkoly E, Schmidtchen A. Results of a non-randomized, open-label phase I study evaluating the novel immunomodulatory peptide TCP-25 for treatment of dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2025 Dec 2;21(1):4. doi: 10.1186/s13023-025-04156-7.
PubMed 41327356
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT06594393
- Acronym / sponsor ID
- STEP / TCP25-002
- Conditions
- Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Keywords
- epidermolysis bullosa, topical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Xinnate ABIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.
Detailed description
The study will include a Screening Period, a Treatment Period (Days 1 to 56, with study visits conducted every 2 weeks, including the baseline [Day 1], Day 14, Day 28, Day 42, and Day 56 visits) and a Safety Follow-up conducted via a telephone/video call at approximately 14 days after the last dose of the IMP. Patients will undergo efficacy, safety, tolerability, and PK assessments at scheduled visits. For evaluation of the primary efficacy endpoint, a trained clinician will take the images of the index wounds at all scheduled visits from baseline through Day 56 (Visit 6) using 3D digital photography and software for wound measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-subject control
| Arm | Type | Receives |
|---|---|---|
| TCP-25 | Experimental | Drug: TCP-25 gelTopical gel |
| Vehicle | Placebo comparator | Drug: Vehicle (placebo)Placebo gel |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping.
- Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.
Key exclusion criteria (6 listed)
- The patient has any subtype of EB other than DEB or JEB.
- The patient is currently being treated or planned to be treated with systemic antibiotics.
- Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.
- Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.
- Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
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 |
|---|---|---|
| TCP-25 gelTopical gel | Drug | TCP-25 |
| Vehicle (placebo)Placebo gel | Drug | Vehicle |
Primary outcome
Open wound area
Time frame: 56 days
8 secondary outcomes
Frequency, intensity, and seriousness of Adverse Events in all treated patients until end of treatment
Time frame: 56 days
Change in procedural pain using the Wong Baker FACES® Pain Rating Scale (0 min -10 max)
Time frame: 56 days
Change from baseline in clinical impression of overall treatment area
Time frame: 56 days
TCP-25 plasma concentrations
Time frame: 56 days
Number of participants with treatment-related local tolerability assessment at the area of IMP application assessed on a 4-point scale
Time frame: 56 days
Clinically significant changes from baseline in blood pressure until end of treatment
Time frame: 56 days
Number of patients with clinically significant changes from baseline in pulse rate until end of treatment
Time frame: 56 days
Number of patients with clinically significant changes from baseline in physical examination findings until end of treatment
Time frame: 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 41327356Wallblom K, Holmgren K, Lundgren S, Belfrage E, Hoppe T, Hugerth M, Lindqvist AK, Sonkoly E, Schmidtchen A. Results of a non-randomized, open-label phase I study evaluating the novel immunomodulatory peptide TCP-25 for treatment of dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2025 Dec 2;21(1):4. doi: 10.1186/s13023-025-04156-7.
- Related InfoLink provided by the sponsor.
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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.
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCP-25 gel in people with Epidermolysis Bullosa (EB) and Dystrophic Epidermolysis Bullosa, run by Xinnate AB at 13 sites in 7 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Greece, Italy, Poland, Sweden and 2 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Development (46462756000, info@xinnate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open wound area (time frame: 56 days). 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 NCT06594393, which also lists 1 linked publication.
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 2 Nov 2026.