What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include mesalamine (5-ASA), glucocorticoids, and biologic agents. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for short-term induction therapy, are associated with systemic side effects like adrenal suppression, increased risk of infection, osteoporosis, and weight gain. Biologic agents, which target specific components of the immune system, can lead to increased risk of infections, infusion reactions, and potential development of antibodies against the medication. These side effects should be discussed with a healthcare provider to tailor the treatment plan to the patient's needs.

What prior FDA approvals exist?

Several advanced treatments for Ulcerative Colitis have received FDA approval. These include biologics such as infliximab, adalimumab, and vedolizumab, which target specific components of the immune system to reduce inflammation. Small molecule drugs like tofacitinib, a Janus kinase (JAK) inhibitor, have also been approved for UC. These treatments are typically used for moderate to severe cases of UC, especially when patients do not respond adequately to conventional therapies like mesalamine or corticosteroids.

What other types of research exist?

Promising novel alternatives to SAR443122 for Ulcerative Colitis patients include: 1) AJM300 (carotegrast methyl), an oral α4-integrin antagonist, which has shown efficacy and safety in a phase 3 study. 2) Anti-IL-23 agents, which target interleukin-23 involved in inflammatory processes. 3) JAK-inhibitors, which block Janus kinase pathways implicated in immune response. 4) S1P modulators, which influence sphingosine-1-phosphate receptors to reduce lymphocyte migration and inflammation.

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SAR443122 for Ulcerative Colitis (RESOLUTE Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12

Summary

This trial is testing SAR443122, a new drug, to see if it can help people with moderate to severe ulcerative colitis by reducing gut inflammation and controlling symptoms. The study will last over a year and includes different phases to assess the drug's effectiveness and safety.

Who is the study for?

Adults with active Ulcerative Colitis for at least 3 months, who haven't responded well to certain treatments like corticosteroids or biologics. They must not have Crohn's Disease, a history of significant infections including COVID-19 recently, or be on conflicting medications. Stable doses of some meds are required and women shouldn't be pregnant or breastfeeding.

What is being tested?

The trial is testing SAR443122 against a placebo in people with moderate to severe Ulcerative Colitis over 52 weeks. It includes an initial treatment phase followed by maintenance or switch to the highest dose if no improvement is seen. The goal is to find the right dose based on safety and effectiveness.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to SAR443122 compared to those taking a placebo. Side effects could range from mild symptoms related to digestion and immune response to more serious complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants who achieve clinical remission at Week 12 by modified Mayo Score (mMS)

Side effects data

From 2023 Phase 2 trial • 78 Patients • NCT04781816

Nasopharyngitis

Pruritus

Arthralgia

Diarrhoea

Alanine Aminotransferase Increased

Dermatitis Contact

Accidental Overdose

Upper Respiratory Tract Infection

Oral Herpes

Viral Upper Respiratory Tract Infection

Back Pain

Tension Headache

Tooth Fracture

Breast Mass

Urinary Tract Infection

Oral Candidiasis

Influenza Like Illness

Peripheral Swelling

Nail Infection

Maculopathy

Odynophagia

Tooth Abscess

Bronchitis

Covid-19

Nausea

Fatigue

Aspartate Aminotransferase Increased

Neutrophil Count Decreased

Urine Protein/Creatinine Ratio Increased

Neck Pain

Headache

Sciatica

Cough

Cutaneous Lupus Erythematosus

Dermatitis Allergic

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

SAR443122

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR443122 level 3Experimental Treatment1 Intervention

Dose level 3

Group II: SAR443122 level 2Experimental Treatment1 Intervention

Dose level 2

Group III: SAR443122 level 1Experimental Treatment1 Intervention

Dose level 1

Group IV: PlaceboPlacebo Group1 Intervention

Matching Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR443122

2020

Completed Phase 2

~150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include TNF inhibitors such as infliximab and adalimumab, which neutralize TNF-alpha, a cytokine involved in inflammation. By inhibiting TNF-alpha, these drugs reduce inflammation and help achieve and maintain remission, which is crucial for managing symptoms and preventing flare-ups. Other treatments include 5-aminosalicylates, which reduce inflammation in the colon lining, and immunomodulators like azathioprine, which suppress the immune response to prevent ongoing inflammation. These mechanisms are vital for improving the quality of life for UC patients.