A First-in-Human trial to investigate how safe, tolerable, effective and how the body handles BEN2293 in patients who have mild to moderate eczema.
- Conditions
- Mild-Moderate Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-003143-28-GB
- Lead Sponsor
- BenevolentAI Bio Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 130
1. Males and females with mild to moderate atopic dermatitis (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.
3. Patient is aged between18 to 65 years, inclusive.
4. Patient has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
5. Body weight of =50 kg.
6. History of atopic dermatitis for at least 6 months diagnosed by a dermatologist or GP.
8. A Validated Investigator’s Global Assessment (vIGA) score of 2 (mild) to 3 (moderate) at both Screening and Day -1.
9. Atopic dermatitis affecting between =5% to =15% Body Surface Area (BSA) of treatable skin (not including face, scalp, hands or soles of feet) at Screening and Day -1 for Cohorts 1 and 2, and between =5% to =30% BSA of treatable skin (not including face, scalp, hands or soles of feet) at Screening and Day -1 for subsequent cohorts.
10. History of AD associated pruritus with an itch score (NRS) of =4. The mean of the pruritus NRS scores (worst itch over the last 24 hours) obtained on Day -3, Day -2 and Day -1 during the emollient only washout phase will be used to assess inclusion.
11. Patients must be willing to stop applying their daily emollients and instead use the study emollient from at least 7 days prior to Day 1 and throughout their participation in the study.
12. Males must use a condom during the trial and for 3 months after their final dose study medication, In addition, their female partner of childbearing potential must be established on an additional method of highly effective contraception prior to dosing until 3 months following final dosing.
13. Female patients of childbearing potential must be established on a highly effective method of contraception prior to dosing until 3 months after last dose in combination with male partner’s use of a condom during the trial and for 3 months after the last dose. Patients must have a negative pregnancy test at Screening and Day 1.
14. Participant has a minimum of one atopic dermatitis area in a site suitable for biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1. 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.
2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
3. Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
4. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet ).
5. 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.
6. Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
7. 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.
12. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti HCV), human immunodeficiency virus I and II (anti-HIV I/II) or SARS-CoV-2 at Screening or Day -1.
17. Supine SBP <90 mmHg >140 mmHg , or DBP <50 mmHg or >90 mmHg after 5 minutes supine and after 3 minutes standing. One repeat is allowed if values are out of range.
22. Patients who have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g., immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics) known or suspected to have an effect on AD, within 3 months prior to screening. All biologics must not have been used within 6 months prior to screening.
23. Patients who have received systemic corticosteroids (e.g. oral, intravenous, intraarticular, rectal) within 8 weeks prior to screening. Patients on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal corticosteroids may participate.
24. Patients treated with oral antihistamines within 7 days of screening; intranasal steroid, antihistamine or sodium cromoglycate sprays for the treatment of allergic rhinitis are acceptable.
25. Patients treated with topical calcineurin inhibitors within 1 month of screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the safety and tolerability of BEN2293, administered as multiple topical doses to increasing body surface areas, in patients with mild to moderate AD.;Secondary Objective: • To investigate the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.<br>• To investigate the effect of BEN2293 on pruritus in patients with mild to moderate AD.<br>• To investigate the effect of BEN2293 on AD in patients with mild to moderate AD.;Primary end point(s): - Adverse events<br>- Local tolerance assessments, vital signs, 12-lead ECG, laboratory safety tests (clinical chemistry, haematology and urinalysis).;Timepoint(s) of evaluation of this end point: - Day (-28) to 14 days post last dose<br>- Maximum evaluated days at Screening, Days 1, 2, 3, 5, 7 and 14. On selected days, these will be measured at pre-dose, 1, 2, 4, 8, 12 and 24 hours post dose<br>
- Secondary Outcome Measures
Name Time Method