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An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials.

An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials.

1672

Overall Number of Participants:1672 <Age, Categorial> Number Analyzed: 1672 participants <=18 years: 103 (6.16%) Between18 and 65 years: 1498 (89.59%) >=65 years: 71 (4.25%) <Age, Mean (Standard Deviation)> Unit of measure: years 37.5 (14.8) <Sex: Female, Male> Number Analyzed: 1672 participants Female: 709 (42.4%) Male: 963 (57.6%) <Ethnicity (NIH/OMB)> Number Analyzed: 1672 participants Hispanic or Latino: 112 (6.7%) Not Hispanic or Latino: 1558 (93.18%) Unknown or Not Reported: 2 (0.12%) <Race/Ethnicity, Customized> Number Analyzed: 1672 participants White 1194 71.41% Black or african american: 120 (7.18%) Asian: 312 (18.66%) American indian or alaska native: 2 (0.12%) Native hawaiian or other pacific islander: 4 (0.24%) Other: 38 (2.27%) Missing: 2 (0.12%) <Region of Enrollment> Number Analyzed: 1672 participants Canada: 237 Belgium: 69 United States: 384 Czechia: 20 Japan: 181 Poland: 228 Italy: 15 United Kingdom: 70 France: 73 Germany: 268 Spain: 127 <Weight (kg)> Number Analyzed:1672 participants Mean (Standard Deviation)　Unit of measure: Kg 77.1 (19.1) <Height (cm) > Number Analyzed: 1672 participants Mean (Standard Deviation)　Unit of measure: cm 170.3 (10.1) <BMI (kg/m^2) > Number Analyzed: 1672 participants Mean (Standard Deviation)　Unit of measure: kg/m^2 26.52 (6.04)

This trial was conducted at 309 sites that screened subjects in 11 countries. Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.

Please see the attached file.

Overall Number of Participants Analyzed: 1672 Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268): 8119

Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 Overall Number of Participants Analyzed:1647 Number (95% Confidence Interval) / Unit of measure: percentage of responders IGA 0/1 at Week 16: 47.3 (44.9 to 49.8) IGA 0/1 at Week 56: 48.5 (45.9 to 51.1) IGA 0/1 at Week 88: 48.6 (46.1 to 51.1) IGA 0/1 at Week 104: 47.1 (44.6 to 49.6) IGA 0/1 at Week 136: 48.7 (46.2 to 51.3) IGA 0/1 at Week 152: 46.8 (44.1 to 49.4) IGA 0/1 at Week 184: 46.7 (44.1 to 49.3) IGA 0/1 at Week 216: 47.2 (44.4 to 50.0) IGA 0/1 at Week 248: 46.9 (44.1 to 49.7) At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 Overall Number of Participants Analyzed 1639 Number (95% Confidence Interval) Unit of measure: percentage of responders EASI75 at Week 16 77.0 (74.9 to 79.0) EASI75 at Week 56 75.2 (72.9 to 77.4) EASI75 at Week 88 75.1 (72.9 to 77.3) EASI75 at Week 104 74.6 (72.3 to 76.8) EASI75 at Week 136 74.1 (71.7 to 76.3) EASI75 at Week 152 73.0 (70.6 to 75.2) EASI75 at Week 184 72.3 (69.7 to 74.6) EASI75 at Week 216 72.1 (69.7 to 74.5) EASI75 at Week 248 71.7 (69.2 to 74.1)

- When treated for up to 5 years, 1421 of the 1672 participants (85%) reported 8119 side effects during the trial. Most of the reported side effects were not serious and were mild to moderate in intensity. - 534 of the 1672 participants (32%) had side effects that the trial doctor thought might be caused by the trial medicine. The most common side effects were: - Worsening of atopic dermatitis (in 65 out of 1672 participants) - Common cold (in 63 out of 1672 participants)

June. 26, 2025

Oct. 01, 2022

https://clinicaltrials.gov/study/NCT03587805?cond=Atopic%20Dermatitis&term=LEO%20Pharma&intr=Tralokinumab&rank=2&tab=results#publications

No

NA

https://cdn.clinicaltrials.gov/large-docs/05/NCT03587805/Prot_000.pdf

LEO Pharma A/S

Industriparken 55 DK-2750 Ballerup Denmark

LEO Pharma A/S

Industriparken 55 DK-2750 Ballerup Denmark

completed

Oct. 02, 2018

Interventional

The trial will include a screening period of 2 weeks (Week 2 to Week 0), a long-term treatment period of approximately 0.5 to 2.5 years, and a 14-week follow-up period for assessment of safety and immunogenicity. The duration of the treatment period for each subject will depend on when they enter the trial after completing the parent trial.

treatment purpose

3

- Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or -1346.
- Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.

- Any condition that required permanent discontinuation of trial treatment in the parent trial.
- More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
- Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 5 half-lives prior to baseline.
- Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline.
- Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational biologic agents
- Clinically significant infection within 4 weeks prior to baseline.
- A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
- Tuberculosis requiring treatment within 12 months prior to screening.
- Known primary immunodeficiency disorder.

Both

Atopic Dermatitis

investigational material(s)
Generic name etc : Tralokinumab
INN of investigational material : Tralokinumab
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational material : 600 mg initial loading dose, then 300 mg every second week (Subcutaneous injection)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

safety
Number of adverse events during the treatment period from baseline up to Week 268

efficacy
- Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ]
The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

- At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial, at Weeks 16, 56, 80, 104, and 128 [ Time Frame: From Week 16 up to Week 128 ]
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.

Dec. 25, 2018