E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety of tralokinumab |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Signed and dated informed consent has been obtained prior to any protocol-related procedures. Signed and dated informed consent for adolescent subjects must be provided by the subject’s legal representative(s) and by the subject in the form of a signed and dated informed assent (as applicable according to national laws or regulations). 2. Subjects must have completed* the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or-1343, -1346, or TRA-WEI-0015-I. 3. Subjects must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. 4. Subjects must be 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). 5. Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days prior to baseline. 6. Female subjects of childbearing potential (defined as Tanner stage ≥3 or menarche)* must use a highly effective** form of birth control (confirmed by the investigator) continuously for at least 1 month prior to the pregnancy test at baseline (Week 0), throughout the trial, and for at least 16 weeks (5 half lives of the IMP) after the last administration of IMP. * A female subject is defined as not being of childbearing potential if she is: •Postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). •Premenarchal- **A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), same sex partner, or vasectomised partner (given that the subject is monogamous).
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E.4 | Principal exclusion criteria |
1.Any condition that required permanent discontinuation of trial treatment in the parent trial 2.More than 26 weeks have elapsed since the subject received the last IMP injection in the parent trial 3.Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator 4.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 5.Receipt of any marketed biological therapy or investigational biologic agent (other than tralokinumab), including immunoglobulin, anti-IgE, or dupilumab: •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 •Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline 6.Treatment with the following medications within 5 half-lives prior to baseline: •Systemic immunosuppressive/immunomodulating drugs (for example, methotrexate, cyclosporine, azathioprine, mycophenolate-mofetil, Janus kinase inhibitors) •Systemic corticosteroids (excluding topical, ophthalmic, inhaled, or intranasal delivery) 7.Treatment with topical PDE-4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline 8.Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb are eligible provided they are vaccinated against hepatitis B and have negative HBsAg and HBcAb 9.Known or suspected hypersensitivity to any component(s) of the IMP 10.History of anaphylaxis following any biological therapy 11.History of immune complex disease 12.History of cancer: •Subjects who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date when informed consent was obtained •Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date when informed consent was obtained 13.Tuberculosis requiring treatment within 12 months prior to screening 14.History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history or subject’s verbal report 15.Current participation in any other interventional clinical trial, except for tralokinumab trials LP0162-1325, 1326, 1334, 1339, 1341, 1342, 1346, 1343, or TRA-WEI-0015-I 17.Receipt of live attenuated vaccines 30 days prior to baseline and during the trial including the safety follow-up period 18.Receipt of blood products within 4 weeks of baseline 19.Major surgery within 8 weeks prior to baseline, or planned in-patient surgery or hospitalisation during the trial 20.History of subject or subject’s legal representative(s) of chronic alcohol or drug abuse within 12 months prior to screening, or any condition (e.g., psychotic state, language barrier or other) associated with poor compliance, as judged by the investigator 21.Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals 22.Subjects who are legally institutionalised 23.Female subjects who are pregnant, breastfeeding, or lactating 24.History of attempted suicide or significant risk of suicide 25.History of a clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator or sponsor’s medical expert, may compromise the safety of the subject in the trial. Clinically significant infections are defined as: •A systemic infection •A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication 26.A helminth parasitic infection within 6 months prior to the date when informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy 27.Any disorder that is not stable and in the opinion of the investigator could: •Affect the safety of the subject throughout the trial •Influence the findings of the trial •Impede the subject’s ability to complete the trial 28.Any abnormal finding which in the opinion of the investigator may: •Put the subject at risk because of their participation in the trial •Influence the results of the trial •Influence the subject’s ability to complete the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of adverse events during the treatment period from baseline up to Week 268 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 2) At least 75% reduction in Eczema Area and Severity Index (EASI75)² relative to baseline in parent trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 19 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 135 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Japan |
United States |
Belgium |
Czechia |
France |
Germany |
Italy |
Poland |
Spain |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 15 |