Upadacitinib for Eczema

Not currently recruiting at 231 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: JAK inhibitors

Disqualifiers: Other skin diseases, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called upadacitinib for individuals with moderate to severe eczema (also known as atopic dermatitis). The goal is to evaluate the effectiveness and safety of this treatment for those who have not found success with creams or other topical treatments and may require medication that works throughout the body. Participants may receive either a placebo (a substance with no active drug) or different doses of upadacitinib to compare results. This trial suits those who have experienced eczema symptoms for at least three years and have not responded well to standard treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop their current atopic dermatitis treatments before starting the study. If you need to continue certain medications, you may not be eligible to participate.

Is there any evidence suggesting that upadacitinib is likely to be safe for humans?

Research shows that upadacitinib is generally safe for individuals with moderate to severe atopic dermatitis. Studies have found its safety profile aligns with earlier research, indicating no new safety concerns. Most reported side effects were mild to moderate. However, some individuals taking upadacitinib may face a higher risk of infections, which can occasionally be serious. This treatment has received approval for use in both adults and teens with atopic dermatitis, confirming its safety for these age groups.

Prospective trial participants should understand these potential risks and benefits. Consulting a doctor is essential to determine if this treatment is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Upadacitinib is unique because it targets the JAK1 enzyme, which plays a crucial role in the inflammatory process of eczema. Unlike standard treatments like topical steroids and calcineurin inhibitors, which primarily reduce inflammation on the skin's surface, upadacitinib works from the inside out by modulating the immune system. This oral medication offers the potential for long-lasting relief and improved skin condition over an extended period, which is why researchers are excited about its promise for those with eczema.

What evidence suggests that upadacitinib might be an effective treatment for atopic dermatitis?

Research shows that upadacitinib effectively treats moderate to severe atopic dermatitis, also known as eczema. In this trial, participants may receive either a placebo or upadacitinib at doses of 15 mg or 30 mg. Studies have found that people taking upadacitinib experience significantly better symptom relief and quality of life than those taking a placebo, which contains no active medicine. Both the 15 mg and 30 mg doses of upadacitinib led to substantial improvements in the Eczema Area and Severity Index (EASI), a tool used to assess eczema severity. Patients experienced clearer skin and less itching, crucial benefits for those with eczema. Additionally, upadacitinib has proven more effective than some other treatments in direct comparisons. These findings suggest that upadacitinib could be a promising option for managing eczema symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who haven't responded well to topical treatments or need systemic therapy. Participants should have a body weight of at least 40 kg if they are between 12 and under 18 years old, and not be pregnant, breastfeeding, or planning pregnancy.

Inclusion Criteria

My eczema is severe, covering more than 10% of my body and itches intensely.

I have had chronic eczema for over 3 years.

My eczema is severe, covering more than 10% of my body and itches intensely.

Exclusion Criteria

I have previously taken medication that targets Janus kinase (JAK).

I do not need medications that are not allowed in the study.

I do not have skin conditions or infections that need strong medication or could affect skin assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive a daily oral dose of upadacitinib or placebo for 16 weeks

16 weeks

Blinded Extension

Participants continue receiving upadacitinib in a blinded manner up to Week 260

244 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo for Upadacitinib
• Upadacitinib

Trial Overview The study is testing the effectiveness and safety of Upadacitinib compared to a placebo in treating atopic dermatitis. It's designed for those who require more than just skin creams or ointments due to the severity of their condition.

How Is the Trial Designed?

Group I: Upadacitinib 30 mg QD Experimental Treatment 1 Intervention

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Group II: Upadacitinib 15 mg QD Experimental Treatment 1 Intervention

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Group III: Placebo / Upadacitinib Placebo Group 2 Interventions

Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study of 901 patients with moderate-to-severe atopic dermatitis, upadacitinib combined with topical corticosteroids (TCS) showed sustained efficacy over 52 weeks, with 50.8% and 69.0% of patients achieving significant skin improvement (EASI-75) at the lower and higher doses, respectively.

The treatment was well tolerated, with no new safety risks identified over the year-long study, and serious adverse events were rare, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. Silverberg, JI., de Bruin-Weller, M., Bieber, T., et al.[2022]

In a real-world study of 43 adults with atopic dermatitis who had previously failed other treatments, including dupilumab, upadacitinib showed rapid and significant improvements in disease severity, with 97.5% of patients achieving at least a 75% reduction in eczema severity by week 16.

The treatment also led to substantial improvements in patients' quality of life, with 76.9% reporting minimal symptoms by week 16, confirming upadacitinib's effectiveness and safety in a population not previously studied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study. Chiricozzi, A., Gori, N., Narcisi, A., et al.[2022]

In a study of 38 patients, upadacitinib demonstrated significant effectiveness in treating atopic dermatitis (AD) and hand eczema (HE), with 50% of patients achieving a 75% improvement in eczema severity (EASI-75) by Week 16.

The safety profile of upadacitinib was consistent with previous clinical trials, indicating it is a safe option for patients with AD and concomitant HE, with no new adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences from daily practice of upadacitinib treatment on atopic dermatitis with a focus on hand eczema: Results from the BioDay registry. Kamphuis, E., Loman, L., Han, HL., et al.[2023]

In a post hoc analysis of three phase 3 trials involving 2583 patients, acne was identified as a common side effect of upadacitinib treatment for atopic dermatitis, affecting 9.8% of patients on 15 mg, 15.2% on 30 mg, and 2.2% on placebo.

Most cases of acne were mild to moderate and did not significantly affect patient quality of life, with many cases requiring no treatment or being managed effectively with topical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. Mendes-Bastos, P., Ladizinski, B., Guttman-Yassky, E., et al.[2022]

Upadacitinib, a selective JAK inhibitor, was well tolerated in a study involving 2485 patients (including 333 adolescents) with moderate-to-severe atopic dermatitis, treated for an average of about one year.

The safety profile showed no new significant risks, with common adverse events being mild, such as acne, and serious adverse events occurring at rates similar to those expected in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. Guttman-Yassky, E., Thyssen, JP., Silverberg, JI., et al.[2023]

In a study of 65 Japanese patients with moderate-to-severe atopic dermatitis, upadacitinib significantly reduced skin rash severity across all anatomical sites after 4, 12, and 24 weeks of treatment.

The treatment was particularly effective for lower limbs, achieving higher rates of improvement compared to the trunk and head and neck areas, indicating varying responsiveness based on the body site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The differential effects of upadacitinib treatment on skin rashes of four anatomical sites in patients with atopic dermatitis. Hagino, T., Saeki, H., Fujimoto, E., et al.[2023]

In a real-life study of 29 patients with severe atopic dermatitis, 79.3% achieved clear or almost clear skin after treatment with upadacitinib for about 54 weeks, demonstrating its effectiveness especially in patients who had previously failed other treatments.

The safety profile of upadacitinib was reassuring, with lipid changes being the most common adverse event, indicating that while monitoring is necessary, the treatment is generally well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Effectiveness and Tolerance of Upadacitinib for Severe Atopic Dermatitis in Adolescents and Adults. De Greef, A., Ghislain, PD., de Montjoye, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02925117

NCT02925117 | A Study to Evaluate ABT-494 ... The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116320/

16-Week Results from Phase 3 Clinical Trials (Measure Up ... Patients who received upadacitinib reported greater improvements in symptoms and quality of life than did patients who received placebo.

3. news.abbvie.com news.abbvie.com/2024-04-25-New-Data-Show-RINVOQ-R-upadacitinib-Demonstrated-Superiority-Versus-DUPIXENT-R-dupilumab-Across-Primary-and-All-Secondary-Endpoints-in-an-Open-Label-Head-to-Head-Atopic-Dermatitis-Study

New Data Show RINVOQ® (upadacitinib) Demonstrated ... Results from this study show that patients with moderate-to-severe atopic dermatitis can strive for both little to no itch and clearer skin.

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2789438

Efficacy and Safety of Upadacitinib in Patients With ... EASI 90/100 indicates 90% or greater/100% improvement in Eczema Area and Severity Index; ITT, intention to treat for the main study; NRS, ...

5. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0306463&type=printable

Efficacy and safety of upadacitinib in the treatment of ... The results revealed that the 15 mg and 30 mg upadacitinib significantly improved Eczema Area and Severity Index (EASI). 75% {[Odds Ratio (OR) = ...

6. rinvoqhcp.com rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis

7. rinvoqhcp.com rinvoqhcp.com/safety

RINVOQ® (upadacitinib) Safety Profile Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death.

8. jacionline.org jacionline.org/article/S0091-6749(22)01327-6/fulltext

Safety of upadacitinib in moderate-to-severe atopic dermatitis Integrated safety data support the use of both upadacitinib 15 mg and 30 mg doses in patients with moderate-to-severe AD who are candidates ...