Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
Study Purpose
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Inclusion Criteria:
- - Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
- - Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- - 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.
Exclusion Criteria:
- - 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 corticosteroid within 4 weeks prior to baseline.
- - Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
- - 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03587805 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
LEO Pharma |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical expert |
Principal Investigator Affiliation | LEO Pharma |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Belgium, Canada, Czechia, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis |
Arms
Experimental: Tralokinumab, all subjects
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.
Interventions
Drug: - Tralokinumab
Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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LEO Pharma Investigational Site
Birmingham, Alabama, 35209
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Birmingham, Alabama, 35233
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Mobile, Alabama, 36695
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Fort Smith, Arkansas, 72916
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Bakersfield, California, 93301
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Beverly Hills, California, 90212
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Encinitas, California, 92024
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San Diego, California, 92119
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Miami, Florida, 33015
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Miami, Florida, 33144
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Address
LEO Pharma Investigational Site
Łódź, , 90-265
Status
Address
LEO Pharma Investigational Site
Łódź, , 90-436
Status
Address
LEO Pharma Investigational Site
Łódź, , 90-752
Status
Address
LEO Pharma Investigational Site
Alicante, , 03010
Status
Address
LEO Pharma Investigational Site
Badalona, , 08915
Status
Address
LEO Pharma Investigational Site
Barakaldo, , 48903
Status
Address
LEO Pharma Investigational Site
Barcelona, , 08003
Status
Address
LEO Pharma Investigational Site
Barcelona, , 08036
Status
Address
LEO Pharma Investigational Site
Barcelona, , 08041
Status
Address
LEO Pharma Investigational Site
Bilbao, , 48013
Status
Address
LEO Pharma Investigational Site
Cordoba, , 14004
Status
Address
LEO Pharma Investigational Site
Fuenlabrada, , 28942
Status
Address
LEO Pharma Investigational Site
Granada, , 18014
Status
Address
LEO Pharma Investigational Site
L'Hospitalet De Llobregat, , 08907
Status
Address
LEO Pharma Investigational Site
Madrid, , 28006
Status
Address
LEO Pharma Investigational Site
Madrid, , 28031
Status
Address
LEO Pharma Investigational Site
Madrid, , 28046
Status
Address
LEO Pharma Investigational Site
Madrid, , 28922
Status
Address
LEO Pharma Investigational Site
Pamplona, , 31008
Status
Address
LEO Pharma Investigational Site
Pontevedra, , 36003
Status
Address
LEO Pharma Investigational Site
Sevilla, , 41007
Status
Address
LEO Pharma Investigational Site
Valencia, , 46014
Status
Address
LEO Pharma Investigational Site
Valencia, , 46026
Status
Address
LEO Pharma Investigational Site
Birmingham, , B15 2TH
Status
Address
LEO Pharma Investigational Site
Cambridge, , CB2 0QQ
Status
Address
LEO Pharma Investigational Site
Cottingham, , HU16 5JQ
Status
Address
LEO Pharma Investigational Site
Dudley, , DY1 2HQ
Status
Address
LEO Pharma Investigational Site
Dundee, , DD1 9SY
Status
Address
LEO Pharma Investigational Site
Harlow, , CM20 1QX
Status
Address
LEO Pharma Investigational Site
Harrogate, , HG2 7SX
Status
Address
LEO Pharma Investigational Site
Leytonstone, , E11 1NR
Status
Address
LEO Pharma Investigational Site
London, , N19 5NF
Status
Address
LEO Pharma Investigational Site
London, , NW3 2QG
Status
Address
LEO Pharma Investigational Site
London, , SE1 9RT
Status
Address
LEO Pharma Investigational Site
Redhill, , RH1 5RH
Status
Address
LEO Pharma Investigational Site
Salford, , M6 8HD
Status
Address
LEO Pharma Investigational Site
Sheffield, , S10 2RX
Status
Address
LEO Pharma Investigational Site
Southampton, , SO16 6YD
Status
Address
LEO Pharma Investigational Site
Wakefield, , WF1 4DG
Status
Address
LEO Pharma Investigational Site
Walsall, , WS2 9PS