Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leo Pharma A/S

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

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

Trial duration

24 Aug 2022 → 30 Apr 2026

Decision date (initial)

2024-09-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512791-36-00

EudraCT number

2021-005573-12

WHO UTN

U1111-1282-4394

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety

To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.

Secondary objectives 2

1. To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD.
2. To evaluate the efficacy of tralokinumab on severity and extent of AD, and on patient-reported outcomes, in children with moderate to-severe AD.

Conditions and MedDRA coding

Treatment of moderate-to-severe Atopic dermatitis

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001900-PIP02-17

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
2. 2. Age 6 to <12 years.
3. 3. Body weight at baseline of ≥17 kg.
4. 4. History of AD for ≥ 12 months at screening.
5. 5. History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
6. 6. AD involvement of ≥10% body surface area at screening and baseline.
7. 7. An EASI score of ≥16 at screening and at baseline.
8. 8. An IGA score of ≥3 at screening and at baseline.
9. 9. Emollient twice daily (or more) for at least 14 days prior to baseline.

Exclusion criteria 11

1. 1. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
2. 2. Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
3. 3. Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline: 3a. Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). 3b. Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery). 3c. 3 or more bleach baths during any week within the 4 weeks.
4. 4. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): 4a. 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. 4b. Other biologics (including dupilumab): within 3 months or 5 half-lives, whichever is longer, prior to baseline.
5. 5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
6. 6. History of malignancy at any time before the baseline visit.
7. 7. History of anaphylaxis following any biological therapy.
8. 8. History of immune complex disease.
9. 9. Active or suspected endoparasitic infections (including helminthic infections).
10. 10. History of past or current tuberculosis or other mycobacterial infection.
11. 11. Established diagnosis of a primary immunodeficiency disorder.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 1. Ctrough at Week 16.
2. 2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
3. 3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level
4. 4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level

Secondary endpoints 9

1. 1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16).
2. 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16).
3. 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68).
4. 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68).
5. 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject)).
6. 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject)).
7. 7. Change in SCORAD from Week 0 to Week 68.
8. 8. Change in POEM from Week 0 to Week 68.
9. 9. Change in EASI from Week 0 to Week 68.

Investigational products

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

Test 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

Third parties 12

Locations

4 EU/EEA countries · 8 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

Documents 24 files

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

Application history

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