A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

A Phase 1/2 study of Atopic Dermatitis, run by BenevolentAI Bio at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, PK and preliminary efficacy of multiple topical doses of BEN2293 in patients with mild to moderate AD. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 123 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Oct 2020to 26 Jan 2023
Phase: Phase 1/2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
History of AD for at least 6 months diagnosed by a dermatologist or GP.
Previous or current successful treatment with topical corticosteroids.
A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part A) and at Screening, Day-3 and Day 1 (Part B).

Who cannot join

Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per Investigator's discretion.
Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder).
The patient has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to Day 1.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

MAC Clinical Research
Manchester, M13 9NQ

Other trials in United Kingdom

About this study

Official title: A First-in-Human, Double-Blind, Randomised, Vehicle Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

Read the detailed description

This Protocol will be adaptive and designed to enable knowledge gained from the previous cohort to be applied to subsequent cohorts. Changes made will be within the boundaries of the adaptive elements with clear control mechanisms and guidance for staying within these boundaries.

Part A is a randomised, double-blind, placebo-controlled, sequential group study to investigate ascending multiple topical doses of BEN2293 in patients with mild to moderate AD. Patients will participate in only one cohort.

Part B is a randomised, double-blind, placebo-controlled, parallel group study to investigate up to two dose regimens of topical doses of BEN2293 administered for a maximum of 28 days in patients with mild to moderate AD.

Conditions: Atopic Dermatitis
Being tested: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BEN2293 (0.25% or 1.0% w/w) or matching placeboDrug
Also called BEN2293
BEN2293 and placebo will be administered as a topical ointment. Both ointments contain the same excipients; placebo ointment has been manufactured in the same way except for the addition of 0.25% and 1.0% (w/w) BEN2293.

Study groups in NCT04737304
Study group	Role	What they receive
Dose Regimen Low Dose	Experimental	Low Dose Strength Receives: Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Dose Regimen High Dose	Experimental	High Dose Strength Receives: Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Placebo	Placebo comparator	Placebo Receives: Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability assessed by means of incidence of adverse events, incidence of adverse events at the local application site, mean vital signs, mean 12-lead ECG parameters and mean safety laboratory results.
Parameters measured by prompted reporting of adverse events and scheduled safety assessments.
Measured: Up to 28 days

Secondary outcomes (19)

PK-Cmax
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Measured: Up to 28 days
PK-Tmax
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Measured: Up to 28 days
PK-T1/2
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Measured: Up to 28 days
PK-AUC
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Measured: Up to 28 days
PK- over a dosing interval (AUCт)
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Measured: Up to 28 days
PK - Accumulation ratio
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients
Measured: Up to 28 days
Time to itch reduction
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Measured: Up to 28 days
Fraction of patients achieving itch reduction
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Measured: Up to 28 days
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Worst Itch over 24 hours
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Measured: Up to 28 days
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Current Itch
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Measured: Up to 28 days
Change from baseline in Eczema Area and Severity Index (EASI) score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Measured: Up to 28 days
Number of patients achieving improvement in Eczema Area and Severity Index (EASI) score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Measured: Up to 28 days
Change from baseline in BSA affected by AD in treated area(s)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Measured: Up to 28 days
Change from baseline in vIGA score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Measured: Up to 28 days
Change from baseline in Patient Oriented Eczema Measure (POEM)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on skin condition graded between 0 - no days to 4 - everyday, with a total score of 28 being the worse.
Measured: Up to 28 days
Change from baseline in Dermatology Life Quality Index (DLQI)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index graded from 0 - not at all to 3 - very much. The higher the score, the more quality of life is impaired.
Measured: Up to 28 days
Change from baseline in EQ5D score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Measured: Up to 28 days
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. System has questions based on Itch - Scratching Behaviour, Itch - Mood and Sleep and Itch - Interference. questions are graded from 1 - never to 5 - almost always (worse score).
Measured: Up to 28 days
Change from baseline in Insomnia Severity Index (ISI)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on quality of sleep, graded 0 - none to 4 - very severe. Total score of 28 being the worse.
Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202026 Jan 2023

First posted3 Feb 2021
Study start14 Oct 2020
Primary completion12 Jan 2023
Study completion26 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04737304
Sponsor's protocol ID: BB-2293-101b
Status last verified: Jun 2023
First submitted: 22 Oct 2020
Last updated: 18 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Human, Double-Blind, Randomised, Vehicle Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
ClinicalTrials.gov ID: NCT04737304
Acronym / sponsor ID: BB-2293-101b
Conditions: Atopic Dermatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: BenevolentAI BioIndustry (pharma, biotech, devices)
Study start: 14 Oct 2020 (actual)
Primary completion: 12 Jan 2023 (actual)
Study completion: 26 Jan 2023 (actual)
First posted: 3 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dose Regimen Low Dose	Experimental	Drug: BEN2293 (0.25% or 1.0% w/w) or matching placeboLow Dose Strength
Dose Regimen High Dose	Experimental	Drug: BEN2293 (0.25% or 1.0% w/w) or matching placeboHigh Dose Strength
Placebo	Placebo comparator	Drug: BEN2293 (0.25% or 1.0% w/w) or matching placeboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
History of AD for at least 6 months diagnosed by a dermatologist or GP.
Previous or current successful treatment with topical corticosteroids.
A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part A) and at Screening, Day-3 and Day 1 (Part B).

Key exclusion criteria (8 listed)

Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per Investigator's discretion.
Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
Patients who are excessively hirsute in areas of skin to be dosed with study ointment.

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
BEN2293 (0.25% or 1.0% w/w) or matching placeboAlso: BEN2293BEN2293 and placebo will be administered as a topical ointment. Both ointments contain the same excipients; placebo ointment has been manufactured in the same way except for the addition of 0.25% and 1.0% (w/w) BEN2293.	Drug	Dose Regimen High Dose, Dose Regimen Low Dose, Placebo

Primary outcome

Safety and tolerability assessed by means of incidence of adverse events, incidence of adverse events at the local application site, mean vital signs, mean 12-lead ECG parameters and mean safety laboratory results.
Time frame: Up to 28 days
Parameters measured by prompted reporting of adverse events and scheduled safety assessments.

19 secondary outcomes

PK-Cmax
Time frame: Up to 28 days
PK-Tmax
Time frame: Up to 28 days
PK-T1/2
Time frame: Up to 28 days
PK-AUC
Time frame: Up to 28 days
PK- over a dosing interval (AUCт)
Time frame: Up to 28 days
PK - Accumulation ratio
Time frame: Up to 28 days
Time to itch reduction
Time frame: Up to 28 days
Fraction of patients achieving itch reduction
Time frame: Up to 28 days
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Worst Itch over 24 hours
Time frame: Up to 28 days
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Current Itch
Time frame: Up to 28 days
Change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Up to 28 days
Number of patients achieving improvement in Eczema Area and Severity Index (EASI) score
Time frame: Up to 28 days
Change from baseline in BSA affected by AD in treated area(s)
Time frame: Up to 28 days
Change from baseline in vIGA score
Time frame: Up to 28 days
Change from baseline in Patient Oriented Eczema Measure (POEM)
Time frame: Up to 28 days
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Up to 28 days
Change from baseline in EQ5D score
Time frame: Up to 28 days
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Up to 28 days
Change from baseline in Insomnia Severity Index (ISI)
Time frame: Up to 28 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 18 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome

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.

Alexander Thompson, MBBS principal investigator

MAC Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Atopic Dermatitis, run by BenevolentAI Bio at 1 site in United Kingdom.

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 4 inclusion and 8 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 18 Jun 2023. 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 Kingdom. 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 combined 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.

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?

Safety and tolerability assessed by means of incidence of adverse events, incidence of adverse events at the local application site, mean vital signs, mean 12-lead ECG parameters and mean safety laboratory results. (time frame: Up to 28 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 NCT04737304.

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 18 Jun 2023.