Upadacitinib for Crohn's Disease

Recruiting at 108 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Pregnancy, Non-compliance, 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

Compensation: Varies

Number of Visits: Unknown

107 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must comply with medication requirements from the previous study, M13-740.

What data supports the effectiveness of the drug Upadacitinib for Crohn's Disease?

Research shows that Upadacitinib, a drug that blocks certain proteins involved in inflammation, helped some patients with Crohn's Disease achieve symptom relief and healing of the gut lining. In studies, it increased the number of patients who felt better and had fewer symptoms over time, and it was generally well-tolerated. ^{1 2 3 4 5}

Is upadacitinib safe for humans?

Upadacitinib has been studied for safety in patients with Crohn's disease, and it was found to be well-tolerated over a 30-month period in a clinical trial. ^{2 4 5 6 7}

How is the drug Upadacitinib different from other treatments for Crohn's disease?

Upadacitinib is unique because it is an oral medication that selectively inhibits Janus kinase 1 (JAK-1), a protein involved in inflammation, and has shown promise in inducing remission in Crohn's disease, which is not yet standard for this condition. It is also being studied for its long-term safety and effectiveness, offering a potential new option for patients who do not respond to existing treatments. ^{1 2 3 4 7}

What is the purpose of this trial?

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for individuals with Crohn's Disease who have completed the M13-740 study up to Week 52. Women must be postmenopausal, surgically sterile, or using birth control. Those unsuitable as per the investigator, pregnant women, or those planning pregnancy during the study are excluded.

Inclusion Criteria

I am a woman who is either postmenopausal, surgically sterile, or using birth control.

Participant must have completed Study M13-740 through Week 52.

I am a woman who is postmenopausal, surgically sterile, or using birth control.

Exclusion Criteria

Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

I am not pregnant nor planning to become pregnant during the study.

For any reason participant is considered by the investigator to be an unsuitable candidate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive repeated administration of Upadacitinib (ABT-494) to evaluate long-term efficacy, safety, and tolerability

Up to 96 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Upadacitinib (ABT-494)

Trial Overview The trial is testing Upadacitinib (ABT-494) for long-term effectiveness and safety in treating Crohn's Disease. It involves repeated doses of this medication over an extended period to monitor its sustained impact on patients.

Participant Groups

Group I: Upadacitinib (ABT-494) Dose B Experimental Treatment 1 Intervention

Open label dose B QD

Group II: Upadacitinib (ABT-494) Dose A Experimental Treatment 1 Intervention

Open label dose A once daily (QD)

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 cohort of patients with medically refractory Crohn's disease, treatment with upadacitinib led to subjective responses in 25% and objective responses in 42% of patients, indicating its potential effectiveness in real-world settings.

Even at lower doses than those currently being studied, upadacitinib demonstrated a favorable benefit-to-risk profile, suggesting it may be a safe option for patients with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib Is Safe and Effective for Crohn's Disease: Real-World Data from a Tertiary Center. Traboulsi, C., Ayoub, F., Silfen, A., et al.[2023]

In two phase 3 trials involving over 1,500 patients with moderate-to-severe Crohn's disease, upadacitinib (45 mg) significantly improved clinical remission and endoscopic response compared to placebo after 12 weeks of treatment.

During the maintenance phase, both 15 mg and 30 mg doses of upadacitinib continued to show superior efficacy in maintaining clinical remission and endoscopic response over 52 weeks, although higher doses were associated with increased risks of herpes zoster infections and other adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. Loftus, EV., Panés, J., Lacerda, AP., et al.[2023]

In a long-term study of 107 patients with Crohn's disease, upadacitinib demonstrated sustained clinical remission rates of around 54-61% over 30 months, indicating its efficacy as a treatment.

While upadacitinib showed long-term benefits, the safety profile revealed that higher doses (30 mg) were associated with increased rates of adverse events compared to lower doses (15 mg), consistent with its known safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. D'Haens, G., Panés, J., Louis, E., et al.[2022]

In a phase 2 trial involving 220 adults with moderate to severe Crohn's disease, upadacitinib demonstrated significant efficacy in inducing endoscopic remission, particularly at the 24 mg dose, compared to placebo.

While upadacitinib showed promising results, it was associated with higher rates of infections and increased cholesterol levels, indicating a need to carefully consider its safety profile in future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease. Sandborn, WJ., Feagan, BG., Loftus, EV., et al.[2021]

Tofacitinib has been evaluated for safety and efficacy in Crohn's disease through two phase II trials, showing no new safety concerns but also no significant improvement over placebo in the primary clinical response measure.

Despite the lack of significant results in larger trials, smaller studies and post hoc analyses suggest that tofacitinib may still provide clinical and biological benefits for some patients with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U: A Multicenter Study From the TROPIC Consortium. Fenster, M., Alayo, QA., Khatiwada, A., et al.[2022]

In a real-world study of 45 patients with moderate to severe Crohn's disease treated with upadacitinib, 63.6% achieved a clinical response and 27.2% achieved clinical remission after 3 months, indicating its efficacy in managing the disease.

The safety profile of upadacitinib was acceptable, with 26.7% of patients experiencing adverse events, and only 4.5% having serious adverse events without any reported mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre Real-world Experience of Upadacitinib in the Treatment of Crohn's Disease. Chugh, R., Braga-Neto, MB., Fredrick, TW., et al.[2023]

References

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

Upadacitinib Is Safe and Effective for Crohn's Disease: Real-World Data from a Tertiary Center. [2023]

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

Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. [2023]

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

In moderate-to-severe Crohn disease, upadacitinib increased clinical remission at 12 and 52 wk. [2023]

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

Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. [2022]

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

Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease. [2021]

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

Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U: A Multicenter Study From the TROPIC Consortium. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Multicentre Real-world Experience of Upadacitinib in the Treatment of Crohn's Disease. [2023]