Atopic DermatitisPhase 2NCT04936113
Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study
A Phase 2 study testing FB-401 in people with Atopic Dermatitis, run by Forte Biosciences, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- FB-401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Jun 2021to 30 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
- Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor
Who cannot join
- Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
- Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
- Pregnant (or planning to become pregnant during the period of the study) or lactating females
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
DS Research
Clarksville, Indiana, 47129
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Cyn3rgy Research
Gresham, Oregon, 97030
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
DS Research
Louisville, Kentucky, 40241
Cyn3rgy Research
New Brighton, Minnesota, 55112
MedaPhase, Inc
Newnan, Georgia, 30263
About this study
Official title: An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.
- Conditions
- Atopic Dermatitis
- Being tested
- FB-401
- Keywords
- Atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Eczematous, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB-401Biological
Topical
| Study group | Role | What they receive |
|---|---|---|
| FB-401 | Experimental | FB-401 applied topically Receives: Biological: FB-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Safety evaluations
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start2 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.
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 Atopic DermatitisStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forte Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936113
- Sponsor's protocol ID
- FB401-02
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
PubMed 29720571
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study
- ClinicalTrials.gov ID
- NCT04936113
- Acronym / sponsor ID
- FB401-02
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Forte Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Jun 2021 (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.
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FB-401 | Experimental | Biological: FB-401FB-401 applied topically |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
- Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor
Key exclusion criteria (3 listed)
- Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
- Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
- Pregnant (or planning to become pregnant during the period of the study) or lactating females
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 |
|---|---|---|
| FB-401Topical | Biological | FB-401 |
Primary outcome
Number of adverse events
Time frame: 52 weeks
Safety evaluations
Results and safety
The study was stopped early (reason given: Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 29720571Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
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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.
8 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 FB-401 in people with Atopic Dermatitis, run by Forte Biosciences, Inc. at 8 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 2 inclusion and 3 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.). 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?
Number of adverse events (time frame: 52 weeks). 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 NCT04936113, 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 28 Oct 2021.