Seladelpar for Primary Biliary Cholangitis

Recruiting in Palo Alto (17 mi)

+195 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you must stop all current medications, but certain medications are prohibited. You must stop using colchicine, methotrexate, azathioprine, long-term systemic steroids, fibrates, obeticholic acid, and any experimental treatments for PBC within specific timeframes before screening. Other medications affecting liver or GI functions may also be prohibited and should be discussed with the medical monitor.

What data supports the idea that Seladelpar for Primary Biliary Cholangitis is an effective drug?

The available research shows that Seladelpar is effective for treating Primary Biliary Cholangitis. In a study, patients who did not respond well to the usual treatment, ursodeoxycholic acid, showed improvement when using Seladelpar. Another study found that Seladelpar helped reduce itching, improve sleep, and decrease tiredness in patients. Additionally, a phase 3 study confirmed that Seladelpar was effective and safe compared to a placebo. Overall, these studies suggest that Seladelpar can be a beneficial option for patients who do not respond to other treatments.

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What safety data is available for Seladelpar in treating primary biliary cholangitis?

Seladelpar has been evaluated for safety in multiple clinical trials for primary biliary cholangitis (PBC). These include a phase 2 double-blind, randomized, placebo-controlled study, an open-label phase 2 study, a phase 2 open-label 52-week study, a phase 3 randomized, placebo-controlled study, and a two-year open-label extension study. These studies assessed the safety and efficacy of Seladelpar in patients with PBC, particularly those with an inadequate response or intolerance to ursodeoxycholic acid. The trials demonstrated that Seladelpar is a selective PPAR-δ agonist with anti-cholestatic, anti-inflammatory, and anti-pruritic effects, and they provided safety data over periods ranging from 3 months to 2 years.

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Is the drug Seladelpar a promising treatment for Primary Biliary Cholangitis?

Yes, Seladelpar is a promising drug for Primary Biliary Cholangitis. It has shown positive effects in improving symptoms like itching and fatigue, and it helps reduce bile acid levels in the blood. Clinical studies have demonstrated its potential to help patients who do not respond well to existing treatments.

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Eligibility Criteria

This trial is for individuals who have previously participated in a seladelpar study for Primary Biliary Cholangitis (PBC), are not pregnant or breastfeeding, and agree to use two forms of birth control. It's not open to those with certain liver conditions, kidney issues, cancer within the last 2 years, chronic viral hepatitis, or on specific medications affecting liver function.

Inclusion Criteria

You have previously participated in a study involving the drug seladelpar for PBC (primary biliary cholangitis).

I am using two forms of birth control during and 90 days after the study.

Must have given written informed consent (signed and dated)

Exclusion Criteria

My liver disease is advanced, with low albumin and high bilirubin levels.

My liver function score is 12 or higher, considering my anticoagulation medication.

I am not pregnant or breastfeeding.

Participant Groups

The safety and tolerability of Seladelpar capsules at doses of 5 mg and 10 mg are being tested over a long term in subjects with PBC. This open-label study allows all participants to know which treatment they're receiving.

Group I: Seladelpar 5 mg Capsules Experimental Treatment 1 Intervention

Group II: Seladelpar 10 mg Capsule Experimental Treatment 1 Intervention

Seladelpar is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Livdelzi for:

• Primary biliary cholangitis

🇪🇺 Approved in European Union as Livdelzi for:

• Primary biliary cholangitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Gastro One-8110 Walnut Run Rd Cordova, TN

Heritage Medical Research Clinic (HMRC) Calgary, Canada

Florida Digestive Health Specialist Lakewood Ranch, FL

University Health Network Toronto, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Gilead Sciences Lead Sponsor

CymaBay Therapeutics, Inc. Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study. [2022] Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid.

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

Seladelpar improved measures of pruritus, sleep, and fatigue and decreased serum bile acids in patients with primary biliary cholangitis. [2022] Primary biliary cholangitis (PBC) can result in life-altering cholestatic pruritus and fatigue, but treatment options are limited. Seladelpar, a peroxisome proliferator-activated receptor-delta (PPARδ) agonist, has demonstrated potent anti-cholestatic effects in clinical studies. This open-label, uncontrolled phase 2 study in PBC patients evaluated the effects of 1-year of seladelpar treatment on measures of pruritus and quality of life.

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

Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study. [2023] ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA).

4. Netherlands pubmed.ncbi.nlm.nih.gov

A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. [2023] We examined the efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, in adults with primary biliary cholangitis (PBC) at risk of disease progression (alkaline phosphatase [ALP] ≥1.67xupper limit of normal [ULN]) who were receiving or intolerant to ursodeoxycholic acid.

5. England pubmed.ncbi.nlm.nih.gov

Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. [2023] Seladelpar is a potent and selective peroxisome proliferator-activated receptor-δ agonist that targets multiple cell types involved in primary biliary cholangitis (PBC), leading to anti-cholestatic, anti-inflammatory and anti-pruritic effects.

6. England pubmed.ncbi.nlm.nih.gov

Seladelpar: an investigational drug for the treatment of early-stage primary biliary cholangitis (PBC). [2023] Generic fibrates are used off-label as add-in therapy for the management of primary biliary cholangitis (PBC) but with unproven long-term liver-related survival benefits. The recently developed fibrate, seladelpar, has shown promising results in clinical trials, but these outcomes have been previously marred by safety concerns.