A Study of GBR 830 in Adult Patients with Atopic Dermatitis
- Conditions
- Moderate to severe atopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-000783-29-LT
- Lead Sponsor
- Inchos Sciences SA (renamed from Glenmark Pharmaceuticals SA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 468
1. Provided written informed consent and any locally required authorization prior to any protocol-related procedures, including screening evaluations.
2. Willing and able to comply with all aspects of the protocol.
3. Male or female =18 years at the time of screening.
4. Physician diagnosis of AD for > 1 year; diagnosis of AD as defined by the American Academy of Dermatology Consensus Criteria (Eichenfeld et al, 2014).
5. AD involvement of =10% Body surface area (BSA) at screening and baseline.
6. EASI score of =12 at screening or =16 at baseline.
7. IGA score of =3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe).
8. Baseline NRS score for maximum itch intensity =3 over the previous 24 hours. A minimum of 3 days of diary completion is required in the week prior to randomization.
9. Documented/reported recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (topical corticosteroids or crisaborole or topical calcineurin inhibitors) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks as defined in the protocol). Documents may include medical records, physician to healthcare provider communication (with date and time of communication and physician signature), or, pharmacy records (with clearly listed dates of dispensation). A course of marketed systemic immunosuppressants (eg, prednisone, cyclosporine, methrotrexate) for AD in the 6 months prior to screening assumes failure of topicals and is acceptable in place of topical failure.
10. Have applied a stable dose of topical emollient (moisturizer) twice-daily for at least 7 consecutive days immediately before the baseline visit (with the exception of prohibited moisturizers containing additives listed in Exclusion Criteria #5).
11. Must agree to the following requirements during the study:
a. If female and of childbearing potential, she must have a negative serum pregnancy test result within 7 days prior to first dosing and a negative urine pregnancy test predose on Day 1. She must be willing to use a highly effective form of contraception (ICH E8 Guideline, 1997; (ICH M3 [R2] Guidance, 2009; (FDA M3 [R2] Guidance, 2010) for the duration of the study and for at least 3 months after the last dose of study medication. Methods like periodic abstinence, post ovulation procedures and withdrawal are not considered adequate. Each woman will be considered to have childbearing potential unless she has been surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy or has been post-menopausal for at least 2 years. For postmenopausal women only, follicle stimulating hormone (FSH) testing will be performed at screening to confirm non-childbearing potential (FSH =40 IU/L).
b. If male with a partner of childbearing potential, he must be willing to use condoms in combination with a second effective method of contraception during the study. Each man will be considered as potent unless surgically sterilized (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate). Male subjects must continue to use contraception for 180 days following administration of the study drug.
c. Male subjects should agree not to donate sperm during the study and for 180 days following administration of the study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adu
1. Prior treatment with GBR 830.
2. Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
3. Concurrent enrollment in another investigational clinical study.
4. Treatment with any of the following before baseline: d. Investigational biological agent within 8 weeks of baseline or 5 half-lives, whichever is longer.
e. Investigational drugs eg, phosphodiesterase type 4 (PDE4) inhibitors, Janus kinase (JAK) inhibitors, within 4 weeks of baseline.
f. Phototherapy for AD within 4 weeks of baseline.
g. Marketed drugs, including systemic corticosteroids, immunosuppressive/immunomodulatory drugs including but not limited to cyclosporine, mycophenolate-mofetil, interferon-gamma (IFN-?), PDE4 inhibitors, JAK inhibitors, azathioprine or methotrexate within 4 weeks of baseline.
h. Topical medications, including corticosteroids, tacrolimus, and/or pimecrolimus, and crisaborole within 1 week of baseline.
i. Regular use (>2 visits/week) of a tanning booth/parlor within 4 weeks of baseline.
j. Biologics, depending on the type of biologic such as cell-depleting agents including but not limited to rituximab: within 6 months of baseline, or until lymphocyte and CD19+ lymphocyte count returns to normal, whichever is longer.
k. Biologics including infliximab, adalimumab, golimumab, certolizumab pegol, abatacept, etanercept, anakinra, dupilumab: within 12 weeks of baseline, or 5 half-lives, whichever is longer.
l. Other biologics: within 5 half-lives (if known).
5. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (subjects may continue using stable doses of such moisturizers if initiated before the screening visit).
6. Planned or anticipated use of any prohibited medications and procedures during study treatment as defined in the study protocol.
7. Subjects who are immunocompromised (congenital or acquired), or who have had a recent (within 3 months prior to baseline) or current serious systemic infection (including infectious mononucleosis-like illness or herpes zoster).
8. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
9. Subjects who have evidence of active or latent tuberculosis (TB) as documented in their medical history or test positive at screening. For indeterminate cases, an informed decision will be made between the Principal Investigator and Medical Monitor.
10. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: subjects may be rescreened after infection resolves.
11. Presence of skin comorbidities that may interfere with study assessments, in the opinion of the Investigator, including subjects with psoriasis.
12. Poorly controlled asthma as assessed by the Asthma Control Questionnaire [ACQ] based on International ERS/ATS guidelines.
13. Any condition at baseline which is part of the criteria for discontinuation of study drug as defined in the study protocol.
14. Subjects who are known to be seropositive for human immunodeficiency virus (HIV) or who test positive at screening.
15. History of a positive result for Hepatitis B surface antigen
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method