ong-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND
- Conditions
- Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-000746-19-GB
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1600
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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety of tralokinumab;Secondary Objective: To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects;Primary end point(s): Number of adverse events during the treatment period from baseline up to Week 268;Timepoint(s) of evaluation of this end point: Week 268
- Secondary Outcome Measures
Name Time Method 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 <br>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 ;Timepoint(s) of evaluation of this end point: Weeks?16, 56, 88, 104, 136, 152, 184, 216, and 248