Upadacitinib for Severe Alopecia Areata
(Up-AA Trial)
Recruiting in Palo Alto (17 mi)
+228 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing upadacitinib, a medication that may help people with severe hair loss due to alopecia areata. The drug works by stopping the immune system from attacking hair roots. Adolescents and adults with severe alopecia areata are participating to see if this treatment is safe and effective.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more information.
What data supports the idea that Upadacitinib for Severe Alopecia Areata is an effective drug?
The available research shows that Upadacitinib helped a young patient with severe alopecia areata grow hair on their scalp and body after just 6 weeks of treatment, even when other treatments like topical corticosteroids didn't work well. This suggests that Upadacitinib can be effective for treating severe alopecia areata. However, compared to other drugs like Baricitinib, which has more robust evidence from multiple trials, the data on Upadacitinib is limited to a single case report.
12345What safety data is available for Upadacitinib in treating severe alopecia areata?
The available safety data for Upadacitinib in treating severe alopecia areata includes a case report describing its successful use in a pediatric patient, where improvements in hair growth were noted after 6 weeks of treatment. No specific adverse events were reported in this case. However, comprehensive safety data from larger clinical trials or studies specifically focused on Upadacitinib for alopecia areata are not provided in the given research.
12346Is the drug Upadacitinib a promising treatment for severe alopecia areata?
The provided research articles do not contain information about Upadacitinib or its effectiveness for treating severe alopecia areata. Therefore, we cannot determine if Upadacitinib is a promising treatment based on this information.
7891011Eligibility Criteria
Adults under 64 and adolescents at least 12 years old with severe alopecia areata (AA) can join this trial. They must have a SALT score ≥50 indicating significant scalp hair loss, no spontaneous hair regrowth in the past 6 months, and stable condition for the last 3 months. The current AA episode should be less than 8 years.Inclusion Criteria
Do you have severe patchy hair loss from alopecia areata?
Have you been diagnosed with Alopecia Areata?
Exclusion Criteria
Have you been diagnosed with other types of hair loss (including male or female pattern baldness)?
Participant Groups
The study tests Upadacitinib's safety and effectiveness against severe AA compared to a placebo. Participants will take oral tablets daily for up to 160 weeks, with chances of being reassigned treatment based on their progress at specific intervals.
17Treatment groups
Experimental Treatment
Group I: Study 3: Group 5 Upadacitinib Dose A (Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
Group II: Study 3: Group 4 Upadacitinib Dose B (Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Group III: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score \> 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Group IV: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)Experimental Treatment1 Intervention
Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Group V: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)Experimental Treatment1 Intervention
Participants receiving upadacitinib Dose A with a SALT score \> 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Group VI: Study 2: Group 6 PlaceboExperimental Treatment1 Intervention
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Group VII: Study 2: Group 5 Upadacitinib Dose BExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Group VIII: Study 2: Group 4 Upadacitinib Dose AExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Group IX: Study 2: Group 3 PlaceboExperimental Treatment1 Intervention
Participants will receive matching placebo once daily for 24 weeks in Period A.
Group X: Study 2: Group 2 Upadacitinib Dose BExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Group XI: Study 2: Group 1 Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Group XII: Study 1: Group 6 PlaceboExperimental Treatment1 Intervention
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Group XIII: Study 1: Group 5 Upadacitinib Dose BExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Group XIV: Study 1: Group 4 Upadacitinib Dose AExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Group XV: Study 1: Group 3 PlaceboExperimental Treatment1 Intervention
Participants will receive matching placebo once daily for 24 weeks in Period A.
Group XVI: Study 1: Group 2 Upadacitinib Dose BExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Group XVII: Study 1: Group 1 Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Upadacitinib is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Rinvoq for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
- Ulcerative colitis
- Crohn's disease
🇺🇸 Approved in United States as Rinvoq for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
- Ulcerative colitis
- Crohn's disease
🇨🇦 Approved in Canada as Rinvoq for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lynde Institute for Dermatology /ID# 258815Markham, Canada
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249Waterloo, Canada
Wiseman Dermatology Research /ID# 258819Winnipeg, Canada
Dermatology Research Institute - Blackfoot Trail /ID# 258818Calgary, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Upadacitinib for the treatment of alopecia areata and severe atopic dermatitis in a paediatric patient: A case report. [2022]This case report describes the first successful treatment of alopecia areata and atopic dermatitis with the Janus kinase 1 inhibitor upadacitinib in a paediatric patient. After minimal response to topical corticosteroids and spironolactone, improvements in hair growth on the scalp and body were noted after only 6 weeks of upadacitinib treatment.
Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. [2022]The phase 2a ALLEGRO trial (NCT02974868) investigated the safety and efficacy of ritlecitinib (PF-06651600) and brepocitinib (PF-06700841) in adults with alopecia areata. No randomized controlled trial for alopecia areata has evaluated correlations between clinician-assessed hair loss and patient-reported outcomes.
Efficacy and safety of ritlecitinib in adolescents with alopecia areata: Results from the ALLEGRO phase 2b/3 randomized, double-blind, placebo-controlled trial. [2023]This subgroup analysis of the ALLEGRO phase 2b/3 trial (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, for the treatment of alopecia areata (AA) in patients aged 12-17 years.
Efficacy of Baricitinib in Patients with Various Degrees of Alopecia Areata Severity: Post-Hoc Analysis from BRAVE AA1 and BRAVE AA2. [2023]Baricitinib, an oral selective JAK1/JAK2 inhibitor, is approved for the treatment of adults with severe alopecia areata (AA).
Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review. [2023]Treatments for alopecia areata (AA) have traditionally been prescribed off-label, and there has been no universal agreement on how to best manage the condition. Baricitinib is the first oral selective Janus kinase (JAK) inhibitor approved for the treatment of adults with severe AA. As a better understanding of the evidence supporting the management of AA in clinical practice is needed, we conducted a systematic literature review and subsequent narrative review to describe available evidence pertaining to the efficacy and tolerability of treatments currently recommended for adults with moderate-to-severe forms of AA. From 2557 identified records, a total of 53 records were retained for data extraction: 9 reported data from 7 randomized controlled trials (RCTs) versus placebo, and 44 reported data from unique RCTs with no placebo arm, non-randomized trials, or observational studies. Across drug classes, data were reported heterogeneously, with little consistency of data collection or clinical endpoints used. The most robust evidence was for the JAK inhibitor class, in particular the JAK1/JAK2 inhibitor baricitinib. Five RCTs (three for baricitinib) demonstrated a consistent benefit of JAK inhibitor therapy over placebo across various clinical outcomes in adult patients with at least 50% scalp hair loss. Overall, hair regrowth varied widely for the other drug classes and was generally low for patients with moderate-to-severe AA. Relapses were commonly observed during treatment and upon discontinuation. Adverse effects were generally consistent with the known safety profile of each intervention. The heterogeneity observed prevented the conduct of a network meta-analysis or an indirect comparison of different treatments. We found that the current management of patients with moderate-to-severe AA often relies on the use of treatments that have not been well evaluated in clinical trials. The most robust evidence identified supported the use of baricitinib, and other oral JAK inhibitors, in patients with severe AA.
Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. [2023]Several non-randomized clinical trials and retrospective studies have demonstrated encouraging efficacy and well-tolerated safety of tofacitinib in the treatment of alopecia areata. However, there are scarce data on a large cohort of patients with alopecia areata in long-term real-world practice. This single-centre, retrospective, observational cohort study included 126 patients with alopecia areata treated with tofacitinib between February 2021 and December 2022. The aims of this study are to evaluate drug survival, effectiveness and safety of tofacitinib for treatment of alopecia areata, and to identify potential factors influencing long-term outcomes. Median duration of treatment was 23.00 (interquartile range (IQR) 15.00, 47.25) weeks. Median all-cause survival time of 126 patients treated with tofacitinib was 44 weeks (95% confidence interval (95% CI) 36.3, 51.7), and the all-cause drug retention rate at 12 weeks, 24 weeks and 48 weeks were 90.0%, 66.4% and 42.3%, respectively. The most common reason for discontinuation was complete remission/satisfaction. A total of 80 patients treated with tofacitinib for over 6 months were included in the efficacy analysis, the overall complete response rate at 24 weeks was 33.8% (27/80). No life-threatening serious adverse events occurred. Sex is an independent risk factor in predicting patient outcomes. This real-world study confirmed the high effectiveness and acceptable safety profile of tofacitinib in alopecia areata, with a satisfactory drug survival rate, and provides supporting data for the clinical application of tofacitinib in Chinese patients with alopecia areata.
BRAF Inhibitor-Induced Panniculitis: Appearance on 18F-FDG PET/CT. [2018]BRAF inhibitors vemurafenib and dabrafenib have become the standard of care for treatment of stage IV metastatic melanoma harboring a BRAF mutation. Panniculitis is a rare but known adverse side effect of these agents and presents with tender erythematous nodules. These nodules may demonstrate uptake on F-FDG PET/CT, which may mimic metastatic disease in patients undergoing treatment. We present a case of BRAF inhibitor-induced panniculitis in a patient with stage IV metastatic melanoma and discuss the imaging findings on F-FDG PET/CT.
Panniculitis and vitiligo occurring during BRAF and MEK inhibitors combination in advanced melanoma patients: Potential predictive role of treatment efficacy. [2020]Panniculitis and vitiligo-like lesions have been recently identified as rare cutaneous side effects of the combination of BRAF and MEK inhibitors, a standard of care in metastatic and locally advanced BRAF V600 mutated melanoma. An immune-mediated mechanism has been advocated in the pathogenesis of these skin lesions. Herein we retrospectively reviewed our institutional experience with the aim to explore the association between the occurrence of panniculitis and vitiligo-like lesions during combination therapy with dabrafenib (D) and trametinib (T) and outcome of advanced melanoma patients. Among 52 consecutive BRAF V600 mutated melanoma patients submitted to DT in our center, 12 (23%) developed immune related skin lesions (IRSLs): 8 panniculitis and 4 vitiligo. Patients with IRSLs diagnosis obtained a better disease response (83% versus 25%) (p = 0.001) than their counterpart and had a longer progression free survival and overall survival. The association of IRSLs and lower risk of disease progression (HR 0.19; CI 95% 0.04-0.90; p = 0.043) was confirmed after adjusting for major prognostic factors in multivariate analysis. IRSLs might represent an easy predictive surrogate marker for treatment response and favourable outcome in melanoma patients submitted to DT combination therapy.
Prospective Case Series of Cutaneous Adverse Effects Associated With Dabrafenib and Trametinib. [2017]Dabrafenib, a novel selective small-molecule inhibitor of BRAF, has been shown to increase overall survival in patients with unresectable metastatic melanoma harboring the BRAF V600E mutation. The development of resistance has led to combination therapy with selective MEK inhibitor trametinib. Compared with vemurafenib, dabrafenib is a more recent BRAF inhibitor approved by the Food and Drug Administration in May 2013 for metastatic melanoma; fewer data are available in the current literature regarding cutaneous toxicity.
Comparative evaluation of the new FDA approved THxID™-BRAF test with High Resolution Melting and Sanger sequencing. [2021]Since patients diagnosed with BRAF V600E and V600K mutated advanced melanoma show response to treatment with MAP kinase inhibitors, several sensitive methods have been developed to determine the V600 allele status of melanoma patients. Vemurafenib (Zelboraf) and dabrafenib (Tafinlar) are specific BRAF V600 inhibitors recently approved by the US FDA as single agent treatments for unresectable or metastatic melanoma in patients with the BRAF V600 mutation.
Open-label, phase IIa study of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma. [2020]This study (NCT02083354) assessed the efficacy and safety of dabrafenib plus trametinib in East Asian patients with advanced BRAF V600-mutant cutaneous melanoma.