Upadacitinib for Atopic Dermatitis

(Flex-Up Trial)

Recruiting at 205 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: AbbVie

Disqualifiers: HIV, Active TB, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

461 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests how flexible the dosing of upadacitinib can be for adults with moderate to severe atopic dermatitis. Participants will take daily tablets for several months, and the study will monitor their response and any side effects. The goal is to find the best way to use this medication for people who need more than just skin creams. Upadacitinib is approved for the treatment of atopic dermatitis in adults and children older than 12 years whose disease is not adequately controlled with other treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Upadacitinib for atopic dermatitis?

Research shows that Upadacitinib, a drug that blocks certain enzymes (JAK-1 inhibitors), is effective for treating moderate-to-severe atopic dermatitis, with positive results in both clinical trials and real-world settings. ^{1 2 3 4 5}

Is upadacitinib safe for humans?

Upadacitinib has been studied in clinical trials for atopic dermatitis, showing a positive benefit-risk profile, but acne is a common side effect. Long-term real-life safety data is still limited. ^{1 2 3 4 6}

How is the drug upadacitinib different from other treatments for atopic dermatitis?

Upadacitinib is unique because it is an oral medication that specifically inhibits Janus kinase 1 (JAK1), which plays a key role in the inflammation process of atopic dermatitis. This makes it different from other treatments that might not target this specific pathway or are not taken orally. ^{1 2 4 7 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults aged 18-64 with moderate to severe atopic dermatitis (eczema) for over 3 years, who need systemic treatment because skin creams aren't enough or suitable. They should have a certain level of itchiness and affected body area. People can't join if they've had recent serious heart issues, organ transplants, allergies to study drug ingredients, high risk of stomach perforation, absorption problems, certain cancers or infections like HIV/TB/herpes or uncontrolled COVID-19.

Inclusion Criteria

I need systemic treatment for my skin condition because topical treatments aren't effective or suitable for me.

I have had chronic eczema for over 3 years.

I often feel severe itching.

Exclusion Criteria

You have had a stroke, heart attack, or certain surgeries in the last 6 months, or have had an organ transplant and need ongoing medication to suppress your immune system. You have had a severe allergic reaction to the study drug or other similar medications, or have a history of certain gastrointestinal problems. You have conditions that could affect how the drug is absorbed, or have had certain types of cancer.

I have not had multiple severe infections or currently have HIV, active TB, or untreated Hepatitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Double-Blind Treatment

Participants are randomized to receive upadacitinib in a double-blind manner for 12 weeks

12 weeks

Regular visits at a hospital or clinic

Single-Blind Treatment

Participants continue treatment with upadacitinib in a single-blind manner for an additional 12 weeks

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Upadacitinib

Trial Overview The trial tests the flexibility of dosing Upadacitinib in pill form for adults with eczema. It includes a double-blind period where participants don't know their dose for 12 weeks followed by another 12-week single-blind period with dose adjustments based on response. The goal is to see how well different doses manage eczema symptoms.

Participant Groups

Group I: Single-Blinded Treatment Period Arm D Experimental Treatment 1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group II: Single-Blinded Treatment Period Arm C Experimental Treatment 1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group III: Single-Blinded Treatment Period Arm B Experimental Treatment 1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group IV: Single-Blinded Treatment Period Arm A Experimental Treatment 1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group V: Double-Blind Treatment Period Dose B Experimental Treatment 1 Intervention

Participants will be administered updadacitinib Dose B once daily (QD) for 12 weeks.

Group VI: Double-Blind Treatment Period Dose A Experimental Treatment 1 Intervention

Participants will be administered updadacitinib Dose A once daily (QD) for 12 weeks.

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

Findings from Research

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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The differential effects of upadacitinib treatment on skin rashes of four anatomical sites in patients with atopic dermatitis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Real-Life Effectiveness and Tolerance of Upadacitinib for Severe Atopic Dermatitis in Adolescents and Adults. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

A real-world Australian experience of upadacitinib for the treatment of severe atopic dermatitis. [2023]

6. United States 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. [2022]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. [2022]