Recessive Dystrophic Epidermolysis BullosaPhase 2NCT04599881
A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa
A Phase 2 study testing PTR-01 in people with Recessive Dystrophic Epidermolysis Bullosa, run by Phoenix Tissue Repair, Inc. at 2 sites in United States.
Trial summary
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Recessive Dystrophic Epidermolysis Bullosa
- What is being tested?
- PTR-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2020to 1 Sep 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for study participation in the three month run in period of the study:
- Willing to provide informed consent form, or if 12 to <18 years of age, legal guardian has provided informed consent form and the minor has signed an assent form acknowledging that they understand and agree to study procedures.
- Has a diagnosis of RDEB based on genetic analysis and consistent with a recessive inheritance pattern.
- Has deficient C7 staining at the dermal-epidermal junction (DEJ) by IF.
- Agrees to use contraception as follows:
- For women of childbearing potential (WOCBP) agrees to use highly effective contraceptive (including abstinence) methods from Screening, through the study, and for at least 10 weeks after the last dose of study drug. Non-childbearing potential is defined as a female who meets either of the following criteria: age ≥50 years and no menses for at least 1 year or documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
- For males, agrees to use a condom with any WOCBP sexual partner from Day 1 of study treatment, through the study, and at least 10 weeks after the last dose of study drug.
- Be willing and able to comply with this protocol.
Who cannot join
- Patients with any of the following will be excluded from participation in the study:
- Has known systemic hypersensitivity to any of the inactive ingredients in PTR-01.
- Has previously had an anaphylactic reaction to PTR-01.
- Is pregnant or nursing.
- Has received in the last six months any investigational gene therapy product or in the last three months any non-gene therapy investigational products.
- Is anticipated to receive new regimens of antibiotics or other anti-infectives during the trial.
- Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Stanford University
Redwood City, California, 94063
About this study
Official title: A Phase 2 Open-Label Study of PTR-01 in Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
Read the detailed description
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
In Part 1, patients will receive a dose of 3.0 mg/kg every week for a total of 4 doses. This will be followed by Part 2 in which patients will receive a dose of 3.0 mg/kg every other week for a total of 7 doses. In Part 3, patients will be followed for 12 weeks. No investigational therapy will be administered during this time. At the end of each dosing period, an efficacy assessment will be performed. Safety will be assessed continuously throughout the study.
Following the end of Part 3, patients may be eligible for a potential long-term extension to further refine the dosing regimen, depending upon study drug availability.
- Being tested
- PTR-01
- Keywords
- RDEB
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTR-01Drug
Also called Recombinant collagen 7, rC7
IV recombinant collagen 7 at 3 mg/kg given weekly for 4 doses, followed by bi-weekly for 7 doses
| Study group | Role | What they receive |
|---|---|---|
| PTR-01 3 mg/kg | Experimental | All patients will receive a PTR-01 dose of 3.0 mg/kg once weekly every week for a total of 4 doses, followed by a dose of 3.0 mg/kg every other week for a total of 7 doses. Receives: Drug: PTR-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Change in a majority of target lesions of at least 2 levels using a 7-point (1-7) Global Impression of Change instrument (7 being the worst)
Measured: Up to 162 days
Incidence of treatment-emergent adverse events
Safety and tolerability, as assessed by treatment-emergent adverse events
Measured: Up to 162 days
Incidence of infusion-associated reactions
Safety and tolerability, as assessed by infusion-associated reactions (IAR)
Measured: Up to 162 days
Incidence of anti-drug antibodies (ADA)
Safety and tolerability, as assessed by immunogenicity through anti-drug antibody (ADA) testing
Measured: Up to 162 days
Secondary outcomes (39)
Delivery of PTR-01 to skin
PTR-01 incorporation by immunofluorescence using NC1 \& NC2 staining, by dose frequency period
Measured: Up to 162 days
Formation of anchoring fibrils
Formation of new anchoring fibrils as measured by electron microscopy
Measured: Up to 162 days
Change in wound surface area, as assessed by wound imaging
Wound area of target lesions, as assessed by wound imaging
Measured: Up to 162 days
Change in wound surface area, as assessed by Investigator Global Impression of Change (IGIC)
Wound area of target lesions, as assessed by IGIC
Measured: Up to 162 days
Change in total body wound surface area
Change in total body wound surface area, using Rule of Nines
Measured: Up to 162 days
Change in skin integrity, as assessed by suction blister time
Change in skin integrity, as assessed by suction blister time
Measured: Up to 162 days
Change in skin integrity, as assessed by time to re-blistering
Change in skin integrity, as assessed by time to re-blistering
Measured: Up to 162 days
Change in itch severity, as assessed by modified Patient-Reported Outcome Measurement Information System (PROMIS) itch domains
Severity of itch, as assessed by modified Patient-Reported Outcome Measurement Information System (PROMIS) itch domains
Measured: Up to 162 days
Change in itch severity, as assessed by the Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB)
Severity of itch, as assessed by Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB), maximum score of 234 (worst)
Measured: Up to 162 days
Change in the impact of itch on quality of life
Change in the impact of itch on quality of life, as assessed by the Pruritus-Specific Quality of Life Instrument (ItchyQoL), maximum score of 110 (worst)
Measured: Up to 162 days
Change in pain severity, as assessed by modified Patient-Reported Outcome Measurement Information System (PROMIS) pain domains
Change in pain severity, as assessed by Patient-Reported Outcome Measurement Information System (PROMIS) pain domains
Measured: Up to 162 days
Change in pain severity, as assessed by the Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB)
Change in pain severity, as assessed by the Instrument for Scoring Clinical, maximum score of 234 (worst)
Measured: Up to 162 days
Change in the impact of pain on quality of life
Change in the impact of pain on quality of life, as assessed by the Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB) instrument, maximum score of 234 (worst)
Measured: Up to 162 days
Change of dysphagia, as assessed using the Brief Esophageal Dysphagia Questionnaire
Change of dysphagia, as assessed using the Brief Esophageal Dysphagia Questionnaire, maximum score is 40 (worst)
Measured: Up to 162 days
Change in dysphagia, as assessed by volume of oral nutritional intake
Change of dysphagia, as assessed by volume of oral nutritional intake, using patient interview and diary, maximum score is 40 (worst)
Measured: Up to 162 days
Stabilization of dysphagia, as assessed using the Brief Esophageal Dysphagia Scale
Stabilization of dysphagia, as assessed using the Brief Esophageal Dysphagia Scale
Measured: Up to 162 days
Stabilization of dysphagia, as assessed by volume oral nutritional intake
Stabilization of dysphagia, as assessed by volume oral nutritional intake, using patient interview and diary
Measured: Up to 162 days
Change in corneal symptoms
Change of corneal symptoms (eye symptoms), as assessed by the Epidermolysis Bullosa Eye Disease Index (EB-EDI)
Measured: Up to 162 days
Stabilization of corneal symptoms
Stabilization of corneal symptoms (eye symptoms), as assessed by the Epidermolysis Bullosa Eye Disease Index (EB-EDI)
Measured: Up to 162 days
Rate of change in nutritional markers (hemoglobin/hematocrit)
Change of nutritional markers, as assessed by hemoglobin/hematocrit
Measured: Up to 162 days
Rate of change in nutritional markers (total protein/albumin)
Change of nutritional markers, as assessed by total protein/albumin
Measured: Up to 162 days
Rate of change in nutritional markers (iron/TIBC)
Change of nutritional markers, as assessed by iron/TIBC
Measured: Up to 162 days
Rate of change in nutritional markers (C-reactive protein)
Change of nutritional markers, as assessed by C-reactive protein
Measured: Up to 162 days
Rate of stabilization of nutritional markers (hemoglobin/hematocrit)
Stabilization of nutritional markers, as assessed by hemoglobin/hematocrit
Measured: Up to 162 days
Rate of stabilization of nutritional markers (total protein/albumin)
Stabilization of nutritional markers, as assessed by total protein/albumin
Measured: Up to 162 days
Rate of stabilization of nutritional markers (iron/TIBC)
Stabilization of nutritional markers, as assessed by iron/TIBC
Measured: Up to 162 days
Rate of stabilization of nutritional markers (C-reactive protein)
Stabilization of nutritional markers, as assessed by C-reactive protein
Measured: Up to 162 days
Change in Investigator Global Impressions of Change (IGIC)
Global impressions of change, as assessed through IGIC (1-7), 7 being worst
Measured: Up to 162 days
Change in Investigator Patient Impressions of Change (PGIC)
Global impressions of change, as assessed through PGIC (1-7), 7 being worst
Measured: Up to 162 days
Change in disease activity and scarring
Change in disease activity and scarring, as assessed by the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI)
Measured: Up to 162 days
Change in overall quality of life, as assessed by the Quality of Life in Epidermolysis Bullosa (QOLEB) questionnaire
Change in overall quality of life, as assessed by the Quality of Life in Epidermolysis Bullosa (QOLEB) questionnaire
Measured: Up to 162 days
Change in overall health
Change in overall disability, as assessed by the Health Assessment Questionnaire or Children's Health Assessment Questionnaire (HAQ/CHAQ)
Measured: Up to 162 days
Change in mental health
Change in mental health and social functioning, as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) mental health domains
Measured: Up to 162 days
Change in social function
Change in mental health and social functioning, as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) social function domains
Measured: Up to 162 days
Change in amount of wound care
Change in amount of wound care, as assessed by patient interviews
Measured: Up to 162 days
Change in time for wound care
Change in time for wound care, as assessed by patient interviews
Measured: Up to 162 daysUp to 162 days
Change in cost of wound care
Change in cost of wound care, as assessed by patient interviews
Measured: Up to 162 days
Change in overall patient impression of quality of life
Change in overall quality of life, as assessed by patient interviews
Measured: Up to 162 days
Change in overall patient impression of disability
Change in overall disability, as assessed by patient interviews
Measured: Up to 162 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start15 Oct 2020
- Primary completion28 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recessive Dystrophic Epidermolysis BullosaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Tissue Repair, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599881
- Sponsor's protocol ID
- PTR-01-002
- Status last verified
- Sep 2021
- First submitted
- 8 Oct 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of PTR-01 in Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)
- ClinicalTrials.gov ID
- NCT04599881
- Acronym / sponsor ID
- PTR-01-002
- Keywords
- RDEB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Phoenix Tissue Repair, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 23 Oct 2020 (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.
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
Detailed description
Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.
In Part 1, patients will receive a dose of 3.0 mg/kg every week for a total of 4 doses. This will be followed by Part 2 in which patients will receive a dose of 3.0 mg/kg every other week for a total of 7 doses. In Part 3, patients will be followed for 12 weeks. No investigational therapy will be administered during this time. At the end of each dosing period, an efficacy assessment will be performed. Safety will be assessed continuously throughout the study.
Following the end of Part 3, patients may be eligible for a potential long-term extension to further refine the dosing regimen, depending upon study drug availability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study
| Arm | Type | Receives |
|---|---|---|
| PTR-01 3 mg/kg | Experimental | Drug: PTR-01All patients will receive a PTR-01 dose of 3.0 mg/kg once weekly every week for a total of 4 doses, followed by a dose of 3.0 mg/kg every other week for a total of 7 doses. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must meet all of the following criteria to be eligible for study participation in the three month run in period of the study:
- Willing to provide informed consent form, or if 12 to <18 years of age, legal guardian has provided informed consent form and the minor has signed an assent form acknowledging that they understand and agree to study procedures.
- Has a diagnosis of RDEB based on genetic analysis and consistent with a recessive inheritance pattern.
- Has deficient C7 staining at the dermal-epidermal junction (DEJ) by IF.
- Agrees to use contraception as follows:
Key exclusion criteria (7 listed)
- Has known systemic hypersensitivity to any of the inactive ingredients in PTR-01.
- Has previously had an anaphylactic reaction to PTR-01.
- Is pregnant or nursing.
- Has received in the last six months any investigational gene therapy product or in the last three months any non-gene therapy investigational products.
- Is anticipated to receive new regimens of antibiotics or other anti-infectives during the trial.
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 |
|---|---|---|
| PTR-01Also: Recombinant collagen 7, rC7IV recombinant collagen 7 at 3 mg/kg given weekly for 4 doses, followed by bi-weekly for 7 doses | Drug | PTR-01 3 mg/kg |
Primary outcome
Wound healing
Time frame: Up to 162 days
Change in a majority of target lesions of at least 2 levels using a 7-point (1-7) Global Impression of Change instrument (7 being the worst)
Incidence of treatment-emergent adverse events
Time frame: Up to 162 days
Safety and tolerability, as assessed by treatment-emergent adverse events
Incidence of infusion-associated reactions
Time frame: Up to 162 days
Safety and tolerability, as assessed by infusion-associated reactions (IAR)
Incidence of anti-drug antibodies (ADA)
Time frame: Up to 162 days
Safety and tolerability, as assessed by immunogenicity through anti-drug antibody (ADA) testing
39 secondary outcomes
Delivery of PTR-01 to skin
Time frame: Up to 162 days
Formation of anchoring fibrils
Time frame: Up to 162 days
Change in wound surface area, as assessed by wound imaging
Time frame: Up to 162 days
Change in wound surface area, as assessed by Investigator Global Impression of Change (IGIC)
Time frame: Up to 162 days
Change in total body wound surface area
Time frame: Up to 162 days
Change in skin integrity, as assessed by suction blister time
Time frame: Up to 162 days
Change in skin integrity, as assessed by time to re-blistering
Time frame: Up to 162 days
Change in itch severity, as assessed by modified Patient-Reported Outcome Measurement Information System (PROMIS) itch domains
Time frame: Up to 162 days
Change in itch severity, as assessed by the Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB)
Time frame: Up to 162 days
Change in the impact of itch on quality of life
Time frame: Up to 162 days
Change in pain severity, as assessed by modified Patient-Reported Outcome Measurement Information System (PROMIS) pain domains
Time frame: Up to 162 days
Change in pain severity, as assessed by the Instrument for Scoring Clinical Outcomes for Research of Epidermolysis Bullosa (iscorEB)
Time frame: Up to 162 days
Change in the impact of pain on quality of life
Time frame: Up to 162 days
Change of dysphagia, as assessed using the Brief Esophageal Dysphagia Questionnaire
Time frame: Up to 162 days
Change in dysphagia, as assessed by volume of oral nutritional intake
Time frame: Up to 162 days
Stabilization of dysphagia, as assessed using the Brief Esophageal Dysphagia Scale
Time frame: Up to 162 days
Stabilization of dysphagia, as assessed by volume oral nutritional intake
Time frame: Up to 162 days
Change in corneal symptoms
Time frame: Up to 162 days
Stabilization of corneal symptoms
Time frame: Up to 162 days
Rate of change in nutritional markers (hemoglobin/hematocrit)
Time frame: Up to 162 days
Rate of change in nutritional markers (total protein/albumin)
Time frame: Up to 162 days
Rate of change in nutritional markers (iron/TIBC)
Time frame: Up to 162 days
Rate of change in nutritional markers (C-reactive protein)
Time frame: Up to 162 days
Rate of stabilization of nutritional markers (hemoglobin/hematocrit)
Time frame: Up to 162 days
Rate of stabilization of nutritional markers (total protein/albumin)
Time frame: Up to 162 days
Rate of stabilization of nutritional markers (iron/TIBC)
Time frame: Up to 162 days
Rate of stabilization of nutritional markers (C-reactive protein)
Time frame: Up to 162 days
Change in Investigator Global Impressions of Change (IGIC)
Time frame: Up to 162 days
Change in Investigator Patient Impressions of Change (PGIC)
Time frame: Up to 162 days
Change in disease activity and scarring
Time frame: Up to 162 days
Change in overall quality of life, as assessed by the Quality of Life in Epidermolysis Bullosa (QOLEB) questionnaire
Time frame: Up to 162 days
Change in overall health
Time frame: Up to 162 days
Change in mental health
Time frame: Up to 162 days
Change in social function
Time frame: Up to 162 days
Change in amount of wound care
Time frame: Up to 162 days
Change in time for wound care
Time frame: Up to 162 daysUp to 162 days
Change in cost of wound care
Time frame: Up to 162 days
Change in overall patient impression of quality of life
Time frame: Up to 162 days
Change in overall patient impression of disability
Time frame: Up to 162 days
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 16 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTR-01 in people with Recessive Dystrophic Epidermolysis Bullosa, run by Phoenix Tissue Repair, Inc. at 2 sites in United States.
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 8 inclusion and 7 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 16 Sep 2021. 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 United States. 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 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 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?
Wound healing (time frame: Up to 162 days). The study lists 4 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 16 Sep 2021.