Title: Study of Solrikitug compared to placebo for adults with Eosinophilic Esophagitis to evaluate its effectiveness and safety

1

What is this study about?

This clinical trial focuses on Eosinophilic Esophagitis (EoE), a chronic inflammatory condition that affects the esophagus (the tube that connects the mouth to the stomach). The study will test a medication called Solrikitug, which is given through subcutaneous injection (an injection under the skin), comparing it with a placebo to determine how well it works in treating inflammation and swallowing difficulties in adults with this condition.

The study consists of two parts. In the first part, participants will receive either Solrikitug or a placebo to evaluate how effectively the medication reduces inflammation in the esophagus and improves swallowing problems. The second part of the study will focus on understanding the long-term safety of the medication. Throughout the study, participants will receive regular medical check-ups and various tests to monitor their condition.

During the trial, participants may receive up to 500 milligrams of Solrikitug per day. The medication will be provided as a powder for injection that will be prepared before use. The study team will monitor participants for any side effects and evaluate how well the treatment works by examining tissue samples from the esophagus and tracking improvement in swallowing ability.

1 Initial screening

Your eligibility will be assessed based on specific criteria, including age (18-75 years), weight (minimum 40 kg), and confirmed diagnosis of eosinophilic esophagitis (EoE).

You must have experienced difficulty swallowing (dysphagia) weekly in the last 4 weeks before screening.

Your diet must have been stable for at least 8 weeks before screening.

2 Medication washout period

If you have been taking certain medications, they need to be stopped before the study:

Stomach acid reducers (PPIs): stop for at least 3 days

Swallowed steroid medications: stop for at least 8 weeks

Previous treatments may continue only if medically necessary and the dose has been stable for at least 8 weeks

3 Part A – Main study phase

Duration: 24 weeks

You will receive either Solrikitug or a placebo through injection under the skin

Regular assessments will include tissue samples and monitoring of swallowing difficulties

Your safety will be monitored through laboratory tests, vital signs, and heart recordings (ECG)

The injection site will be checked regularly

4 Part B – Extension phase

Duration: Additional 28 weeks (until week 52)

Continued treatment and monitoring of safety and effectiveness

Regular tissue samples will be taken to check inflammation levels

Ongoing assessment of swallowing difficulties

Regular safety monitoring will continue

5 Study completion

Final evaluations will be performed

Total study duration: approximately 52 weeks

All study activities will conclude by January 31, 2027

Who Can Join the Study?

  • Age between 18 and 75 years old at the time of signing consent to participate
  • Body weight must be at least 40 kilograms during initial screening
  • Must have a confirmed diagnosis of Eosinophilic Esophagitis (EoE) before or during screening
  • Must have experienced difficulty swallowing (dysphagia) at least weekly in the 4 weeks before screening
  • Must have previous treatment with proton pump inhibitors (PPIs) – medications that reduce stomach acid. If stopping PPI treatment, must wait at least 3 days before screening
  • If previously treated with swallowed topical corticosteroids (anti-inflammatory medications), must stop treatment at least 8 weeks before screening
  • Must maintain a stable diet for at least 8 weeks before screening
  • If continuing any standard treatments, the dose must remain unchanged for at least 8 weeks and continue throughout the study
  • Cannot be using dupilumab (a medication for allergic conditions) during the study

Who Cannot Join the Study?

  • History of any autoimmune disorders (conditions where the immune system attacks healthy cells)
  • Current or recent use of systemic corticosteroids (medications that reduce inflammation throughout the body) within 4 weeks before the study
  • Active gastrointestinal infections or conditions other than Eosinophilic Esophagitis
  • History of major surgery of the gastrointestinal tract
  • Current malignancy (cancer) or history of cancer in the past 5 years
  • Severe liver disease or abnormal liver function tests
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • Known allergies to the study medication or its components
  • Immunocompromised condition (weakened immune system)
  • Significant heart, kidney, or lung disease
  • Inability to follow study procedures or attend scheduled visits
  • Use of prohibited medications that might interfere with the study drug

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
Ip Clinic Sp. z o.o. Lodz Poland
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
centre Hospitalier de Wallonie Picarde Tournai Belgium
Azienda Ospedaliera di Padova Padua Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Sint-Lucas General Hospital Brugge Belgium
Universita’ Di Pisa Pisa Italy
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Hospital General De Tomelloso Tomelloso Spain
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Hceldnto Ukdficdjfesyk Dr Lz Phnidwgy Madrid Spain
Aainqetad Uci Amsterdam The Netherlands
Ecqzmrv Uroimslkusol Mjlwgde Cycahie Rploxlhlx (atmmrsi Myq Rotterdam The Netherlands
Nbjkmaam Iitcjwyf Ocgrnbqht Iqq Mfoko Sxlbzpnubwvsnbceilpxqpsiiotr Ihyizubl Bhwjoixm Cracow Poland
Ukjcutrzdb Dnjcl Swwcf Dy Rcuy Lv Sjjipbwt Rome Italy
Wna Wdvwdk Ixv Picde Pkdkwafw Koyrqtl Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.12.2024
Italy Italy
Not recruiting
01.12.2024
Poland Poland
Not recruiting
01.12.2024
Spain Spain
Not recruiting
01.12.2024
The Netherlands The Netherlands
Not recruiting
01.12.2024

Trial locations

Investigated drugs:

Solrikitug is an investigational medication being studied for the treatment of Eosinophilic Esophagitis (EoE), a condition where the esophagus becomes inflamed due to an excess of white blood cells called eosinophils. This medication is being tested to see if it can reduce inflammation in the esophagus and improve symptoms of difficulty swallowing (dysphagia) in adults with EoE. It is being evaluated both for its immediate effects and long-term safety when used over an extended period.

Investigated diseases:

Eosinophilic Esophagitis – A chronic inflammatory condition that affects the esophagus, characterized by the buildup of white blood cells called eosinophils in the esophageal tissue. The inflammation causes the esophagus to become stiff and narrow, making it difficult for food to pass through. People with this condition often experience trouble swallowing, food getting stuck in the throat, chest pain, and heartburn. The condition typically develops slowly over time and can affect both children and adults.

Trial ID:
2024-510849-34-00
Protocol code:
NSI-8226-201
NCT ID:
NCT06598462
Trial Phase:
Therapeutic exploratory (Phase II)

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