Randomized, placebo-controlled, double-blind phase III study of Upadacitinib in adolescent and adult participants with moderate to severe atopic dermatitis
Descrizione riassuntiva dello studio
Atopic dermatitis (AD) is a skin condition that can cause rashes and itching due to skin inflammation. Topical therapies may not be sufficient to control AD in patients who require systemic anti-inflammatory treatments by mouth or by injection under the skin or into the vein. This is a phase 3 study for adolescents (12-17 years) and adults (18-75 years) with moderate to severe AD who are eligible for systemic treatment. Patients will receive treatment with Upadacitinib / placebo. Upadacitinib is an investigational drug currently being developed for the treatment of AD. This study will investigate how well Upadacitinib works in the body and how safe it is compared to placebo (tablet without active ingredient).
(BASEC)
Intervento studiato
Approximately N=810 patients will be enrolled at about 185 sites worldwide.
The study includes a 35-day screening period, followed by a 16-week double-blind treatment period and a 120-week blinded continuation phase (duration approximately 2.5 years).
Patients will be randomized in a 1:1:1 ratio to receive daily oral doses of Upadacitinib Dose A (N = 270) or Dose B (N = 270) or a corresponding placebo (N = 270). At week 16, participants in the placebo group will be randomized 1:1 again to receive daily oral doses of Upadacitinib Dose A or Dose B during the blinded continuation phase.
Patients initially in the Upadacitinib Dose A or Dose B group will continue their treatment until week 136.
Patients will attend regular study visits in the hospital or clinic. The effect of the treatment on the skin will be assessed through dermatological examinations, blood tests, monitoring for side effects, and completion of questionnaires. There will be additional optional blood tests to see why some people respond better to the medication than others.
(BASEC)
Malattie studiate
Atopic Dermatitis (eczema)
(BASEC)
• Male or female participants aged 12-75 years • Active moderate to severe atopic dermatitis, defined by EASI, IGA, BSA, and pruritus. • Candidate for systemic therapy or has recently required systemic therapy for atopic dermatitis (BASEC)
Criteri di esclusione
• prior exposure to JAK inhibitors • Unable or unwilling to discontinue current AD treatments prior to the study. • The patient has used the following AD treatments within the specified time frame prior to the baseline visit: • Systemic therapy for AD within 4 weeks (corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, interferon-γ, and mycophenolate mofetil) • Targeted biological treatments within 12 weeks • Phototherapy treatment within 4 weeks (laser therapy, tanning bed, or prolonged sun exposure that may affect the severity of the condition or impair the assessment of the condition) • Other active skin diseases or skin infections requiring systemic treatment or that may impair the assessment of atopic dermatitis. • Female who is pregnant, breastfeeding, or considering pregnancy during the study. (BASEC)
Luogo dello studio
Basilea, Berna, Ginevra, Losanna
(BASEC)
Sponsor
AbbVie Inc. AbbVie AG Cham CH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Informazioni generali
AbbVie
(ICTRP)
Informazioni scientifiche
AbbVie
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
18.12.2018
(BASEC)
ID di studio ICTRP
NCT03607422 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis (BASEC)
Titolo accademico
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (ICTRP)
Titolo pubblico
A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2) (ICTRP)
Malattie studiate
Atopic Dermatitis (ICTRP)
Intervento studiato
Drug: Upadacitinib;Drug: Placebo for Upadacitinib (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years
of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline
- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI),
Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Documented history (within 6 months prior to Baseline) of inadequate response to
topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
systemic treatment for AD or for whom topical treatments are otherwise medically
inadvisable due to side effects or safety risks
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study
(ICTRP)
non disponibile
Endpoint primari e secondari
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline;Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at Least Two Grades of Reduction from Baseline (ICTRP)
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 from Baseline for Participants with Worst Pruritus NRS = 4 at Baseline;Percentage of Participants Achieving EASI 90;Percentage of Participants Achieving EASI 75;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose A;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose B;Percentage of Participants Experiencing a Flare;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score = 12 (Minimal Clinically Important Difference (MCID)) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score = 4 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) = 28 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score = 11 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score = 14 (MCID) from Baseline;Percentage of Participants Achieving EASI 100 (ICTRP)
Data di registrazione
25.07.2018 (ICTRP)
Inclusione del primo partecipante
27.07.2018 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
AbbVie Inc., AbbVie (ICTRP)
ID secondari
2018-001383-28, M18-891 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT03607422 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile