24 completed, 5 terminated, 4 recruiting, 1 not yet recruiting. 13 Phase 3, 10 Phase 2, 6 Phase 1, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 11, Recruiting 1, Terminated 1 |
| Phase 2 | 10 | Completed 8, Terminated 2 |
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Phase 4 | 3 | Not yet recruiting 1, Terminated 1, Unknown 1 |
Follow tralokinumab: new trials by email Literature Review of tralokinumab trials Research Report on tralokinumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Utilization of a Microdevice for Psoriasis and Atopic Dermatitis In situ cutaneous microdevice, Triamcinolone, 5-Fluorouracil - Psoriasis, Atopic Dermatitis | Phase 4 | Not yet recruiting | University of California, San Francisco | 10 | 2026-08-01 | 2026-06-03 |
| Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact tralokinumab - Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region | Recruiting | University Hospital Schleswig-Holstein | 30 | 2025-10-20 | 2026-03-03 | |
| A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis Tralokinumab + TCS, Placebo + TCS - Atopic Dermatitis | Phase 3 | Recruiting | LEO Pharma | 195 | 2024-06-10 | 2026-07-07 |
| Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Second-line systemic treatment, Folllow-up of second-line systemic treatment already started - Atopic Dermatitis | Phase 4 | Unknown | Instituto de Investigación Hospital Universitario La Paz | 150 | 2023-09-25 | 2024-04-16 |
| Tralokinumab for Dupilumab Failures tralokinumab - Atopic Dermatitis | Phase 4 | Terminated | Psoriasis Treatment Center of Central New Jersey | 7 | 2023-09-11 | 2026-05-22 |
| A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy Tralokinumab, Placebo - Atopic Dermatitis, Atopic Hand Eczema | Phase 3 | Completed | LEO Pharma | 235 | 2023-08-28 | 2026-10-22 |
| Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT Tralokinumab - Atopic Dermatitis, Eczema | Recruiting | University of California, San Diego | 900 | 2022-12-08 | 2025-01-28 | |
| Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Tralokinumab - Atopic Dermatitis | Phase 2 | Completed | LEO Pharma | 28 | 2022-09-07 | 2026-05-14 |
| Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA) Tralokinumab - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 136 | 2022-01-13 | 2025-03-11 |
| Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Tralokinumab, Placebo, Topical corticosteroids (TCS) - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 106 | 2020-10-27 | 2025-03-11 |
| Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Tralokinumab - Atopic Dermatitis | Phase 2 | Completed | Prof. Dr. Stephan Weidinger | 16 | 2020-09-28 | 2023-04-21 |
| Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 Tralokinumab, Placebo - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 277 | 2018-12-13 | 2025-03-11 |
| Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 Tralokinumab, Caffeine, Warfarin - Atopic Dermatitis | Phase 1 | Completed | LEO Pharma | 40 | 2018-08-13 | 2025-02-24 |
| Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5) Tralokinumab, Placebo, Tdap vaccine - Atopic Dermatitis | Phase 2 | Completed | LEO Pharma | 215 | 2018-07-13 | 2025-03-11 |
| Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Tralokinumab, Placebos - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 301 | 2018-06-19 | 2025-03-11 |
| Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND Tralokinumab - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 1672 | 2018-03-18 | 2025-03-11 |
| Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 Tralokinumab, Placebo - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 380 | 2018-02-22 | 2025-03-11 |
| Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) Tralokinumab, Placebo - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 794 | 2017-06-12 | 2025-03-11 |
| Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) Tralokinumab, Placebo - Atopic Dermatitis | Phase 3 | Completed | LEO Pharma | 802 | 2017-05-30 | 2025-03-11 |
| Molecular Signatures in Inflammatory Skin Disease Anti-TNF, Anti-IL12/23, Anti-IL17 - Atopic Dermatitis, Psoriasis | Recruiting | Prof. Dr. Stephan Weidinger | 300 | 2017-01-20 | 2025-07-22 |
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Dermatitis, Atopic (20) · Asthma (11) · Lung Diseases (3) · Lung Diseases, Obstructive (2) · Psoriasis (2) · Respiratory Tract Diseases (2) · Alopecia (1) · Alopecia Areata (1) · Alopecia universalis (1) · Colitis, Ulcerative (1) · Eczema (1) · Idiopathic Pulmonary Fibrosis (1) · Inflammatory Bowel Diseases (1)
LEO Pharma (13) · MedImmune LLC (9) · AstraZeneca (5) · Prof. Dr. Stephan Weidinger (2) · Emma Guttman (1) · Instituto de Investigación Hospital Universitario La Paz (1) · Psoriasis Treatment Center of Central New Jersey (1) · University Hospital Schleswig-Holstein (1) · University of California, San Diego (1) · University of California, San Francisco (1)
United States (21) · Germany (16) · Poland (14) · United Kingdom (14) · Canada (10) · France (10) · Spain (10) · Belgium (8) · Netherlands (8) · Japan (6) · South Korea (6) · Czechia (5) · Australia (4) · Italy (4) · Argentina (2)
Edward Piper, MBBS (2) · Andreas Wollenberg, Prof. Dr. med. (1) · Barbara Cook, MD (1) · Christopher Brightling (1) · Christopher Brightling, MD (1) · Emma Guttman, MD, PhD (1) · Eric Simpson, MD, MCR (1) · Joseph Parker, MD (1) · Katsuro Yagawa, M.D. (1) · Mark Berner Hansen, MD, PhD (1) · Raymond Cho, MD, PhD (1)
PMID 29536781, PMID 40555305, PMID 41118053, PMID 36152216, PMID 40085349, PMID 28758192, PMID 33000465, PMID 37682422, PMID 37804473, PMID 25304132, PMID 25614165, PMID 28787186, PMID 29792288, PMID 29793857, PMID 30649752, PMID 31315668, PMID 35537502, PMID 35671038, PMID 35857179, PMID 36473633, PMID 37074705, PMID 38563683, PMID 39733934, PMID 40681936, PMID 40721559, PMID 40879371, PMID 41102518, PMID 41642555, PMID 42033591, PMID 42825999
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