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TMB-001 Ointment for Ichthyosis (ASCEND Trial)
Phase 3
Waitlist Available
Research Sponsored by Timber Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented history of moderate to severe disease at Screening
Subject has clinical diagnosis of CI and has a genetic confirmation of either ARCI or RXLI subtypes of CI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
ASCEND Trial Summary
This trial is testing a topical ointment for the treatment of chronic idiopathic urticaria (CIU). The trial is designed to test the safety and efficacy of the ointment, and will enroll subjects with either the RXLI or ARCI subtypes of CIU. The trial will be conducted in three periods: induction (3 weeks), treatment (9 weeks), and maintenance (12 weeks).
Who is the study for?
This trial is for males and females aged 6 and older with a clinical diagnosis of Congenital Ichthyosis (CI), specifically RXLI or ARCI subtypes, confirmed by genetics. Participants must have significant skin scaling and be in good health. Women who can bear children must use two forms of birth control. Those pregnant, lactating, or planning pregnancy; using certain treatments like UV therapy or systemic immunosuppressants; with untreated infections; drug/alcohol abuse history; on other trials; failed retinoid therapies; liver/kidney issues are excluded.Check my eligibility
What is being tested?
The study tests TMB-001 ointment's safety and effectiveness against CI compared to a placebo (vehicle). It has three phases over 24 weeks: an initial induction period with once-daily treatment, increased to twice daily during the main treatment phase, followed by maintenance where dosing frequency may vary based on response. An optional arm studies systemic exposure in those with extensive affected skin.See study design
What are the potential side effects?
Potential side effects aren't specified but could include reactions at the application site such as redness, itching, or irritation given it's a topical medication. Systemic side effects might occur if absorption through the skin happens but would depend on individual patient factors.
ASCEND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition was moderate to severe at my last check-up.
Select...
I have been diagnosed with congenital ichthyosis and confirmed to have ARCI or RXLI.
Select...
I am a woman who is either postmenopausal, cannot have children, or I use two forms of birth control.
ASCEND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Investigator global assessment (IGA) score
Secondary outcome measures
Change in Visual Index of Ichthyosis Severity score
To investigate the proportion of subjects experiencing local skin reactions with topically applied TMB-001 0.05% ointment.
ASCEND Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TMB-001 0.05%Experimental Treatment1 Intervention
TMB-001 0.05% ointment: Induction phase QD for 3 weeks, followed by BID for 9 weeks. Maintenance therapy for additional 12 weeks randomized QD vs BID
Group II: Maximal useExperimental Treatment1 Intervention
Optional Parallel Arm to evaluate the systemic exposure and safety of TMB-001 0.05% under conditions of maximal use.
Group III: VehiclePlacebo Group1 Intervention
Matching vehicle ointment with no action isotretinoin: Induction phase QD for 3 weeks, followed by BID for 9 weeks. Cross over to 12 weeks TMB-001 0.05% BID.
Find a Location
Who is running the clinical trial?
Timber Pharmaceuticals Inc.Lead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Ichthyosis
34 Patients Enrolled for Ichthyosis
Timber Pharmceuticals LLCLead Sponsor
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Ichthyosis
34 Patients Enrolled for Ichthyosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a skin or physical condition that could affect the study's safety or results.Your liver or kidney function tests are significantly higher than normal.I am 6 years old or older.I am on immunotherapy or have a weakened immune system.Your baseline assessment must show that specific areas have a score of 3 or higher.I have a confirmed genetic form of congenital ichthyosis affecting 10-90% of my skin.My condition was moderate to severe at my last check-up.I am a woman not able to have children, using strong birth control, or have been without a period for over a year if I'm over 50.I have suspicious or untreated skin lesions in the areas to be treated.You need to have a score of 3 or higher in at least 2 out of 4 assessment areas.I have given my written consent to participate, or if under 18, my guardian has consented for me.I have not used UV treatment in the last 4 weeks.I haven't taken vitamin A supplements or St. John's Wort in the last 4 weeks.Your IGA score in the treatment area at the start of the study must be 3 or higher.I have been taking immunosuppressive drugs, including steroids, within the last 2 weeks.I have infections that haven't been treated yet.I have tried retinoid therapy for my condition without success.I have skin conditions that could affect study results, not related to ichthyosis.I have used prescribed or OTC skin treatments recently.I am 6 years old or older.I have used TMB-001 or oral isotretinoin in the last year.I am able to communicate and cooperate with my doctor without any issues.75% to 90% of my skin is affected by my condition.I have used skin products on the treatment area by my second visit.I have a genetic condition related to a specific type of severe skin disorder.I have been diagnosed with congenital ichthyosis and confirmed to have ARCI or RXLI.I am a woman who is either postmenopausal, cannot have children, or I use two forms of birth control.75% to 90% of my skin is affected by my condition.The affected skin in the treatment area should be between 10% and 90% of the total body surface area.
Research Study Groups:
This trial has the following groups:- Group 1: TMB-001 0.05%
- Group 2: Vehicle
- Group 3: Maximal use
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ichthyosis Patient Testimony for trial: Trial Name: NCT05295732 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be taking part in this study at the most?
"One hundred and forty-two individuals that fit the pre-stated inclusion criteria are required to enroll in this clinical trial. US Derm Partners in Phoenix, Arizona and Stanford Children's Health in Palo Alto, California are two of the medical sites where patients can participate in this study."
Answered by AI
Are there any side effects to taking TMB-001?
"TMB-001 has been given a safety score of 3 by our team at Power. This is because it is a Phase 3 trial, which demonstrates some efficacy and multiple rounds of data supporting safety."
Answered by AI
In how many places is this research being done?
"This clinical trial is being conducted at 18 different sites, including Stanford Children's Health in Palo Alto, Medical Dermatology Specialists (US Derm Partners) in Phoenix, and About Skin Dermatology in Centennial, among other locations."
Answered by AI
Are there any unfilled positions in this experiment?
"The trial is definitely still recruiting patients if you refer to the information on clinicaltrials.gov. To be more specific, the trial was first posted on June 21st, 2022 and was edited more recently on July 6th, 2022. In total, the study needs 142 patients from 18 different locations."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Wake Forest University Health Sciences
Why did patients apply to this trial?
I need help managing my HS. I have kerotosis and old age spots over much of my body and scalp. My dr freezes them off. She tells me they aren't moles.
PatientReceived 1 prior treatment
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