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NCT05938478: PROTECT
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
trial testing Tralokinumab in Atopic Dermatitis in 900 participants. Currently enrolling.
30 November 2034
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 900 |
| Start date | 8 December 2022 |
| Primary completion | 30 November 2034 |
| Estimated completion | 30 September 2035 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tralokinumab (TRALOKINUMAB) — full drug profile →
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
- Eczema — all drugs for Eczema →
Sponsor
University of California, San Diego
Who can join
Eligibility, female only, with Atopic Dermatitis or Eczema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: * Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery * Release medical records for pregnancy and for their child * Complete an online survey about their baby's development at 4 months and 12 months of age * May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
IL-13 inhibition in the treatment of atopic dermatitis - new and emerging biologic agents.
Teixeira C, Yilmaz O, Bernardo D, Torres T. · · 2024 · cited 7× · PMID 39558725 · DOI 10.1177/03000605241286832
Verify or expand the search:
- PubMed search for NCT05938478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tralokinumab
Trials testing the same drug.
- NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
- NCT05958407 — A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Ecze · Phase 3 · completed
- NCT05388760 — Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Tria · Phase 2 · active not recruiting
- NCT05194540 — Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe At · Phase 3 · completed
- NCT04587453 — Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis · Phase 3 · completed
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
- NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
- NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
- NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
- NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
Other University of California, San Diego trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05938478 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 28 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05938478.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing