Randomized, placebo-controlled, double-blind phase III study of Upadacitinib in adolescent and adult participants with moderate to severe atopic dermatitis
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Basel, Bern, Genf, Lausanne
(BASEC)
Sponsor
AbbVie Inc. AbbVie AG Cham CH
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Franzisca Rusca
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie Medical Information
(BASEC)
Allgemeine Auskünfte
AbbVie
(ICTRP)
Wissenschaftliche Auskünfte
AbbVie
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
18.12.2018
(BASEC)
ICTRP Studien-ID
NCT03607422 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis (BASEC)
Wissenschaftlicher Titel
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (ICTRP)
Öffentlicher Titel
A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2) (ICTRP)
Untersuchte Krankheit(en)
Atopic Dermatitis (ICTRP)
Untersuchte Intervention
Drug: Upadacitinib;Drug: Placebo for Upadacitinib (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
25.07.2018 (ICTRP)
Einschluss des ersten Teilnehmers
27.07.2018 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
AbbVie Inc., AbbVie (ICTRP)
Sekundäre IDs
2018-001383-28, M18-891 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT03607422 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar