Upadacitinib for Eczema

(Measure Up 1 Trial)

No longer recruiting at 214 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, upadacitinib, for individuals with moderate to severe eczema (atopic dermatitis) who may require stronger systemic treatments. Researchers aim to determine the medication's effectiveness and safety. Participants will receive a daily dose of upadacitinib in two different strengths or a placebo (a pill with no active medicine) for a short period, followed by upadacitinib. The trial seeks individuals who have had eczema for at least three years, have not responded well to creams or ointments, and frequently experience severe itching. As a Phase 3 trial, this study 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 certain medications that are not allowed during the study, you may not be eligible to participate.

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

Research has shown that upadacitinib is generally safe for treating atopic dermatitis, also known as eczema. Studies have found that most side effects, such as eczema herpeticum (a type of skin infection), are not serious. Specifically, only one or two cases of this infection were reported in both the 15 mg and 30 mg dose groups. Upadacitinib is already approved for use in adults and teens aged 12 and older with moderate to severe eczema, supporting its safety. While side effects can occur, they are usually mild and manageable. ^{1 2 3 4 5}

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

Researchers are excited about upadacitinib for eczema because it offers a different approach compared to many standard treatments like topical steroids or calcineurin inhibitors. Upadacitinib is a JAK inhibitor, which means it works by targeting specific enzymes (Janus kinases) that play a crucial role in the inflammation process of eczema. This unique mechanism can potentially provide more effective control of eczema symptoms with an oral medication, offering convenience over topical applications. Additionally, the option to adjust doses, as seen with the 15 mg and 30 mg options, allows for tailored treatment based on individual patient needs, which is a significant advantage over one-size-fits-all treatments.

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

Research has shown that upadacitinib effectively treats moderate to severe atopic dermatitis, also known as eczema. In this trial, participants may receive either 15 mg or 30 mg of upadacitinib daily, or a placebo initially, followed by upadacitinib. Studies have demonstrated that individuals taking upadacitinib experienced greater improvement in symptoms and quality of life compared to those taking a placebo, which contains no active medicine. Upadacitinib has significantly reduced itching and cleared eczema rashes. Many patients have reported achieving clearer skin with little to no itching. Overall, evidence supports upadacitinib as a promising option for those needing strong treatment for moderate to severe eczema. ^{1 2 3 6 7}

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 weigh at least 40 kg, have a history of inadequate response to certain topical treatments, and are candidates for systemic therapy. Participants should not be pregnant or breastfeeding, must discontinue other eczema treatments before the study, and cannot have used JAK inhibitors previously.

Inclusion Criteria

I have used a moisturizer twice a day for at least a week.

Your eczema is very severe, with a score of 16 or higher on a special scale.

Your skin condition is rated as moderate or worse by the study doctor at the screening and baseline visits.

Exclusion Criteria

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

I do not have active skin diseases or infections that need systemic treatment.

I cannot or do not want to stop my current skin treatment before the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Double-blind 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

up to 260 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib

Trial Overview The trial is testing Upadacitinib's effectiveness in treating moderate to severe eczema compared to a placebo. It aims to see if this drug can improve symptoms in those who haven't responded well enough to topical therapies.

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 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 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]

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]

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 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-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]

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]

Citations

1. 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.

2. 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 ...

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. rinvoq.com rinvoq.com/atopic-dermatitis/rinvoq-results/results-with-rinvoq

RINVOQ® (upadacitinib) Results for Adults with Eczema ... RINVOQ helps heal your painful skin in two ways—by significantly reducing the itch and clearing the rash of eczema · Two 16-week clinical trials tested the ...

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

Safety of upadacitinib in moderate-to-severe atopic dermatitis Safety results were similar between the 16-week and all upadacitinib exposure groups. The latter group included 2485 patients (333 adolescents), ...