A trial to evaluate the efficacy and safety of different doses of LEO 138559 in adults with moderate-to-severe atopic dermatitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leo Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

6 Nov 2023 → 3 Apr 2025

Decision date (initial)

2023-10-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

LEO Pharma A/S

External identifiers

EU CT number

2022-500777-14-00

WHO UTN

U1111-1286-0955

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Dose response, Pharmacodynamic, Safety, Therapy

To compare the efficacy of 4 different dosage regimens of LEO 138559 with placebo in subjects with moderate-to-severe AD.

Secondary objectives 1

1. To compare the safety of 4 different dosage regimens of LEO 138559 with placebo in subjects with moderate-to-severe AD.

Conditions and MedDRA coding

Atopic Dermatitis

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 18-75 years old (both included) at screening (Visit 1).
2. At screening, diagnosis of - AD as defined by the Hanifin and Rajka (1980) criteria for AD. History of AD for ≥1 year.
3. Subjects who have a recent history (within 12 months before screening) with documented inadequate response to treatment with TCS (±TCI as appropriate) or for whom these topical AD treatments are medically inadvisable (e.g. due to important side effects or safety risks).
4. EASI score ≥12 at screening and ≥16 at baseline.
5. vIGA-AD score ≥3 at screening and baseline.
6. BSA of AD involvement ≥10% at screening and baseline.
7. ADSD Worst Itch score (weekly average) ≥4 at baseline.

Exclusion criteria 13

1. History of clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject’s ability to participate in the trial. Clinically significant infections are defined as: - a systemic infection. - a serious skin infection requiring parenteral (IV or intramuscular) antibiotics, antiviral, or antifungal medication.
2. Non-serious skin infection within 7 days prior to baseline.
3. Presence of hepatitis B or C infection at screening.
4. History of HIV infection or positive HIV serology at screening.
5. Evidence of active or latent tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment.
6. Women who are pregnant or breastfeeding.
7. Previous exposure to fezakinumab (anti-IL-22 Ab).
8. Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), corticosteroids (steroid eyedrops and inhaled or intranasal steroids are allowed), or JAK inhibitors within 28 days or 5 half-lives prior to baseline, whichever is longer.
9. Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 4 weeks prior to baseline.
10. Receipt of blood products within 28 days prior to screening.
11. Treatment with: - Any marketed or investigational biologic agents within 3 months or 5 half-lives, whichever is longer, prior to baseline. - Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
12. Treatment with TCS, TCI, topical PDE-4 inhibitors, topical JAK inhibitors, or other medicated topical treatments within 7 days prior to baseline
13. Receipt of live attenuated vaccines 30 days prior to baseline.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change in EASI score from baseline to Week 16

Secondary endpoints 1

1. Number of TEAEs recorded for each subject from baseline to Week 16.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leo Pharma A/S

Sponsor organisation

Leo Pharma A/S

Address

Industriparken 55

City

Ballerup

Postcode

2750

Country

Denmark

Scientific contact point

Organisation

Leo Pharma A/S

Contact name

LEO Pharma Clinical Trials mailbox

Public contact point

Organisation

Leo Pharma A/S

Contact name

LEO Pharma Clinical Trials mailbox

Locations

7 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 65 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications