A Phase 1/2 interventional study of BEN2293 (0.25% or 1.0% w/w) or matching placebo in Atopic Dermatitis, sponsored by BenevolentAI Bio. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by BenevolentAI Bio · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 125 studies in Dermatitis, Atopic with a site in United Kingdom — 12 open to participants now, 24 under way, 7 of them phase 3. Dermatitis, Atopic · United Kingdom.
Among the 125 studies in Dermatitis, Atopic with a site in United Kingdom, this one is the 73rd largest by enrollment of the 110 interventional ones that give a count, is one of 6 that started in 2020, is one of 4 in phase 1/2, and was the 80th registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →12 of the 125 studies in Dermatitis, Atopic with a site in United Kingdom are open now. Recruiting first, the newest first:
King's College London · Sites in United Kingdom
Ages 0 mo–6 mo · Healthy volunteers
Chong Kun Dang Pharmaceutical · Sites in United Kingdom, Germany
Ages 18–55 · Healthy volunteers
Galderma R&D · Sites in United Kingdom, United States, Germany
Ages 12+
Novartis Pharmaceuticals · Sites in United Kingdom, United States, Argentina and 14 more countries
Ages 18–100
Apogee Therapeutics, Inc. · Sites in United Kingdom, United States, Canada and 6 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 39 · Phase 3 44 · Phase 4 8
First in 1998; this study’s year is marked. 6 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 123 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 231 across the 110 interventional studies, 325 across the 14 observational. Of the 97 that completed or were terminated, 52 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 125 have an industry lead sponsor. The 10 most frequent:
BenevolentAI Bio is the lead sponsor of 3 studies on the registry; none are open to participants now.
BenevolentAI Bio has 1 study filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
7 of the studies in Dermatitis, Atopic with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT06395948Apogee Therapeutics, Inc.A Study Evaluating APG777 in Atopic Dermatitis | 2026-11 |
| NCT07358156Chong Kun Dang PharmaceuticalA Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants. | 2026-11-16 |
| NCT07228962King's College LondonCutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies | 2026-12-30 |
| NCT05983068SanofiA Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis | 2027-04-29 |
Add all 7 to your calendar (.ics) → With an account.
Among the 125 studies in Dermatitis, Atopic with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low Dose Strength
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
High Dose Strength
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Placebo
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
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.
Also known as: BEN2293
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.
Time frame: Up to 28 days
PK-Cmax
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 28 days
PK - Accumulation ratio
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 28 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Jan 2023, 26 months.
Of 25 industry-sponsored phase 1/2 interventional studies under Dermatitis, Atopic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 26 months is above that.
Counting every sponsor, half of 29 studies reached it within 22 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.