Adalimumab for Pediatric Ulcerative Colitis

No longer recruiting at 27 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Unsuitable candidate

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

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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 288 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of adalimumab, a biologic medication, for children with ulcerative colitis, a condition causing inflammation and sores in the colon. The study examines how well this medication works over an extended period. Children who completed a previous related study might be eligible to join this trial. Participants will receive adalimumab for up to 288 weeks to assess its impact on symptom management. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator.

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

Research has shown that adalimumab is generally safe for children with ulcerative colitis. Studies have found no new safety concerns when used in children with moderate-to-severe ulcerative colitis, and most children tolerate the treatment well.

In one study, nearly half of the children managed well without needing steroid medication after a year. Another study found that some children experienced healing in the lining of their colon.

The FDA has also approved adalimumab for other conditions, indicating that its safety is well understood. Overall, the evidence supports adalimumab as a safe option for children with ulcerative colitis. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for ulcerative colitis?

Unlike the standard treatments for pediatric ulcerative colitis, which often rely on corticosteroids or aminosalicylates, Adalimumab is a biologic that specifically targets and blocks tumor necrosis factor-alpha (TNF-alpha), a key player in the inflammation process. This targeted approach can reduce inflammation more effectively and with fewer side effects than traditional therapies. Researchers are excited about Adalimumab because it offers the potential for long-term management of the condition, possibly improving quality of life for young patients who may not respond well to other medications.

What evidence suggests that adalimumab might be an effective treatment for pediatric ulcerative colitis?

Research has shown that adalimumab, which participants in this trial will receive, may help treat children with ulcerative colitis. In studies, about 53% of children who took adalimumab experienced a reduction or disappearance of symptoms by week 8. Another study found significant improvement in symptoms and inflammation by week 52. These results suggest that adalimumab could help manage symptoms and improve health in children with this condition. No new safety issues emerged, which is reassuring for long-term use. ^{1 2 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 children with ulcerative colitis who have finished the M11-290 study. It's not open to those whom the investigator thinks shouldn't participate for any reason.

Inclusion Criteria

Subject must have successfully enrolled and completed M11-290 study

Exclusion Criteria

Subject considered by the investigator, for any reason, to be an unsuitable candidate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Adalimumab for up to 288 weeks to assess long-term safety and efficacy

288 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Open-label extension

Participants may continue to receive Adalimumab beyond the initial treatment period

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Adalimumab

Trial Overview The trial is looking at how safe and effective Adalimumab, a medication used to treat inflammatory conditions, is over a long period in kids with ulcerative colitis.

How Is the Trial Designed?

Group I: Subjects receiving Adalimumab Experimental Treatment 1 Intervention

Subjects receiving Adalimumab up to 288 weeks

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in United States as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis
• Hidradenitis suppurativa

Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34153231/

Efficacy and safety of adalimumab in paediatric patients ... Remission rates in the pooled adalimumab groups were significantly better compared with external placebo (PMS remission at week 8: 41 [53%] of ...

2. humirapro.com humirapro.com/pediatric-ulcerative-colitis

HUMIRA® (adalimumab) for Pediatric Ulcerative Colitis (UC) View the efficacy and safety data of HUMIRA in pediatric patients with Ulcerative Colitis (UC). See Important Safety Information, including BOXED WARNING.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02065557

NCT02065557 | Efficacy and Safety of Adalimumab in ... The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in ...

4. academic.oup.com academic.oup.com/ibdjournal/article/31/8/2184/7954627

Effectiveness and Safety of Adalimumab in Patients With Very ... Patients with VEO-IBD treated with adalimumab presented significant improvement in clinical scores and inflammatory markers by Week 52, whereas ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125321001424

Efficacy and safety of adalimumab in paediatric patients ... Clinically meaningful rates of remission and response were reported in children who received adalimumab in this study. No new safety signals were observed, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02632175

NCT02632175 | Long-term Safety and Efficacy Study of ... Study Overview. This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29315163/

Efficacy and Safety of Adalimumab in Pediatric Ulcerative ... Fifty-two weeks after ADA initiation, 13 patients (41%) were in corticosteroid-free remission. Mucosal healing occurred in 9 patients (28%) at 52 weeks. The ...

8. academic.oup.com academic.oup.com/ibdjournal/article-abstract/31/8/2184/7954627

Effectiveness and Safety of Adalimumab in Patients With Very ... Adalimumab durability rates were 61.9%, 48.1%, and 35.6% after 1, 2, and 3 years, respectively. Drug discontinuation rates were not dependent on ...