Hidradenitis SuppurativaPhase 1NCT04541550
Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
A Phase 1 study testing AMP-001 Low Dose, AMP-001 Medium Dose and AMP-001 High Dose in people with Hidradenitis Suppurativa, run by IntegoGen, LLC at 1 site in United States.
Trial summary
This study is an open-label, dose-escalation study enrolling 15 participants. There are 3 cohorts: 1. Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline) 2. Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline) 3. 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?
- AMP-001 Low Dose, AMP-001 Medium Dose and AMP-001 High Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Phase 1
- 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
- Age ≥18 years
- Can understand the nature of the procedure, and provide, or have a legal representative provide, a written informed consent.
- Clinically diagnosed with Hidradenitis Suppurativa characterized as Hurley Score, Stage II or Stage III.
- History of standard-of-care supportive treatment failure with corticosteroids and/or antibiotics within 30 days before the baseline visit.
- Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit.
- No prior history of a biologic product or Humira for the treatment of Hidradenitis Suppurativa.
Who cannot join
- Intolerance or unwillingness to participate in all procedure(s) or medication(s) required of this protocol.
- Diagnosis or reported history of any of the folding conditions:
- Uncontrolled Diabetes Mellitus (HbA1c ≥9);
- Severe Morbid Obesity (BMI≥40);
- Chronic heart, renal, or hepatic disease;
- Neurodegenerative debilitating conditions, and
Show all 17Show fewer
- Cancer.
- The participant is currently receiving or has received within 3 months before enrollment, medications or treatments that are known to affect the wound healing process, including but not limited to: chronic systemic steroid intake, history of recent changes in the participant's tissue integrity (i.e., thin, fragile skin with multiple hematomas or previous lacerations), current use of immune-suppressive drugs, radiation therapy, immunomodulating medications, and chemotherapy.
- The participant has received HS micronized amnion therapy in the last 90 days.
- Systolic blood pressure greater than 190 or less than 90 mmHg.
- Diastolic blood pressure greater than 105 or less than 50 mmHg.
- Early, symptomatic autonomic dysfunction.
- Abuse of prescription drugs, illegal substances, and/or alcohol.
- Females who are pregnant, nursing, or of childbearing potential and not using a reliable birth control method (such as, female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge or gels, in addition to male use of a condom) or the female should be using prescribed "birth control" pills, injections, or implants. or who intend to become pregnant during their participation in the study.
- Clinically significant abnormal laboratory values at the time of the screening or baseline visit.
- Exposure to the investigational product within 3 months prior to enrollment or anticipate participation in any other investigational drug study or other interventional studies while enrolled in the study.
- In the opinion of the Principal Investigator, the participant should not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Houston Dermatology Laser and Skin Care Center
Houston, Texas, 77082
About this study
Official title: An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
This study is an open-label, dose-escalation study enrolling 15 participants.
There are 3 cohorts:
- Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline)
- Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline)
- Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).
Read the detailed description
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent deep-seated boil-like abscesses and tracts under the skin. The most severe HS lesions are characterized by chronic non-healing sinuses, which form a wound-like environment as the abscesses heal; they produce significant skin scarring. Transcriptomic analysis of lesioned skin from HS patients suggests that it has similar pathology to other chronic wounds. IntegoGen's investigational product, IGN-AMP001, is manufactured from the amniotic membrane of the human placenta. The amnion membrane contains various cytokines and growth factors that promote wound healing. Local application of micronized dehydrated amnion membrane has been shown effective in treating chronic refractory non-healing dermal wounds of various etiologies in randomized clinical trials and case studies, which suggests it might be effective in treating HS wounds as well. Patients treated with IGN-AMP001 within IntegoGen associated clinics and other regenerative clinics have indicated positive responses. This study is designed to evaluate the safety, tolerability, and potential efficacy of IGN-AMP001 for HS.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- AMP-001 Low Dose, AMP-001 Medium Dose, AMP-001 High Dose
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMP-001 Low DoseDrug
Also called 12.5 mg AMP-001
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
AMP-001 Medium DoseDrug
Also called 25 mg AMP-001
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
AMP-001 High DoseDrug
Also called 50 mg AMP-001
AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose AMP-001 | Experimental | 12.5 mg AMP-001 in 3 ml Saline Receives: Drug: AMP-001 Low Dose |
| Medium Dose AMP-001 | Experimental | 25 mg AMP-001in 3 ml Saline Receives: Drug: AMP-001 Medium Dose |
| High Dose AMP-001 | Experimental | 50 mg AMP-001 in 3 ml Saline Receives: Drug: AMP-001 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: Study didn't proceed to FDA submission
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntegoGen, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Mahoney, MD, Principal investigator, West Houston Dermatology Laser and Skin Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541550
- Sponsor's protocol ID
- INT-001
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04541550
- Acronym / sponsor ID
- INT-001
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study didn't proceed to FDA submission
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IntegoGen, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 9 Sep 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.
This study is an open-label, dose-escalation study enrolling 15 participants.
There are 3 cohorts:
- Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline)
- Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline)
- Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).
Detailed description
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent deep-seated boil-like abscesses and tracts under the skin. The most severe HS lesions are characterized by chronic non-healing sinuses, which form a wound-like environment as the abscesses heal; they produce significant skin scarring. Transcriptomic analysis of lesioned skin from HS patients suggests that it has similar pathology to other chronic wounds. IntegoGen's investigational product, IGN-AMP001, is manufactured from the amniotic membrane of the human placenta. The amnion membrane contains various cytokines and growth factors that promote wound healing. Local application of micronized dehydrated amnion membrane has been shown effective in treating chronic refractory non-healing dermal wounds of various etiologies in randomized clinical trials and case studies, which suggests it might be effective in treating HS wounds as well. Patients treated with IGN-AMP001 within IntegoGen associated clinics and other regenerative clinics have indicated positive responses. This study is designed to evaluate the safety, tolerability, and potential efficacy of IGN-AMP001 for HS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose AMP-001 | Experimental | Drug: AMP-001 Low Dose12.5 mg AMP-001 in 3 ml Saline |
| Medium Dose AMP-001 | Experimental | Drug: AMP-001 Medium Dose25 mg AMP-001in 3 ml Saline |
| High Dose AMP-001 | Experimental | Drug: AMP-001 High Dose50 mg AMP-001 in 3 ml Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Can understand the nature of the procedure, and provide, or have a legal representative provide, a written informed consent.
- Clinically diagnosed with Hidradenitis Suppurativa characterized as Hurley Score, Stage II or Stage III.
- History of standard-of-care supportive treatment failure with corticosteroids and/or antibiotics within 30 days before the baseline visit.
- Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit.
Key exclusion criteria (17 listed)
- Intolerance or unwillingness to participate in all procedure(s) or medication(s) required of this protocol.
- Diagnosis or reported history of any of the folding conditions:
- The participant is currently receiving or has received within 3 months before enrollment, medications or treatments that are known to affect the wound healing process, including but not limited to: chronic systemic steroid intake, history of recent changes in the participant's tissue integrity (i.e., thin, fragile skin with multiple hematomas or previous lacerations), current use of immune-suppressive drugs, radiation therapy, immunomodulating medications, and chemotherapy.
- The participant has received HS micronized amnion therapy in the last 90 days.
- Systolic blood pressure greater than 190 or less than 90 mmHg.
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 |
|---|---|---|
| AMP-001 Low DoseAlso: 12.5 mg AMP-001AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells. | Drug | Low Dose AMP-001 |
| AMP-001 Medium DoseAlso: 25 mg AMP-001AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells. | Drug | Medium Dose AMP-001 |
| AMP-001 High DoseAlso: 50 mg AMP-001AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells. | Drug | High Dose AMP-001 |
Primary outcome
Total number of Adverse Events
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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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.
Stephen Mahoney, MD principal investigator
West Houston Dermatology Laser and Skin Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMP-001 Low Dose, AMP-001 Medium Dose and AMP-001 High Dose in people with Hidradenitis Suppurativa, run by IntegoGen, LLC at 1 site 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 6 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: withdrawn, as of the sponsor's last update on 8 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 1 site 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 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Total number of Adverse Events (time frame: 6 months). 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 8 Sep 2021.