2025-522750-39-00
Recruiting
Phase 3
A randomized, phase 3, double-blind, double-dummy, active comparator-controlled multicenter clinical trial to evaluate the efficacy and safety of linaprazan glurate compared to lansoprazole in maintenance of healing in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D
Cinclus Pharma Holding AB (publ)41 sites in 3 countries63 target enrollmentStarted: April 28, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Cinclus Pharma Holding AB (publ)
- Enrollment
- 63
- Locations
- 41
- Primary Endpoint
- 1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.
Overview
Brief Summary
To confirm non-inferiority of linaprazan glurate ‘high dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this trial if the following criteria apply:
- •The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.
- •The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial.
- •The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device [e-device] completion, etc.).
Exclusion Criteria
- •An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria:
- •EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy >14 days before the last regular visit in the preceding healing trial).
- •Current or history of alcohol, drug abuse, and/or use of androgens/anabolic steroids (testosterone and testosterone esters [enanthate, undecanoate, cypionate], methyltestosterone, oxandrolone, stanozolol, fluoxymesterone, danazol, tetrahydrogestrinone, 7α-methyl-19-nortestosterone) within 2 years prior to Run-in Period. Stable androgen substitution treatment for male hypogonadism is allowed.
- •Women who are pregnant or breast feeding
- •Individual is an employee of the Investigator, trial site, Sponsor, or Contract Research Organization (CRO) with direct involvement in the proposed trial or other trials under the direction of that Investigator, trial site, Sponsor, or CRO, as well as family members of the employee of the Investigator, trial site, Sponsor, or CRO.
- •Individuals who have previously participated (completed or withdrawn) in this trial.
- •A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner and who is unwilling to routinely use highly effective contraception from the signing of the ICF until 7 days after the last dose of IP.
- •A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to agree to not father a child from the signing of the ICF until at least 7 days after the last dose of IP.
- •Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett’s esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.
- •Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator.
Arms & Interventions
LANSOPRAZOLE, LANSOPRAZOLE
Comparator
Intervention: LANSOPRAZOLE (Drug)
Linaprazan glurate
Test
Intervention: Linaprazan glurate (Drug)
Placebo to match Linaprazan Glurate
Placebo
Intervention: Placebo to match Linaprazan Glurate (Drug)
Placebo to match lansoprazole high dose, Placebo to match Lansoprazole low dose
Placebo
Intervention: Placebo to match lansoprazole high dose (Drug)
Placebo to match lansoprazole high dose, Placebo to match Lansoprazole low dose
Placebo
Intervention: Placebo to match Lansoprazole low dose (Drug)
Outcomes
Primary Outcomes
1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.
1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.
Secondary Outcomes
- 1. Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy
- 2. Maintained healing from EE as assessed by central reading of endoscopy after 24 weeks in participants with Baseline EE due to GERD of LA grades C/D.
- 3. Percentage of heartburn-free days from Baseline to Week 24 based on electronic Diary
- 4. Maintained healing of EE comparing linaprazan glurate ‘high dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy.
- 5. Maintained healing of EE comparing linaprazan glurate ‘low dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy
Investigators
Rikard Reneland
Scientific
Cinclus Pharma Holding AB (publ)
Study Sites (41)
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