Long-term safety and effectiveness study of verekitug injections in adults with severe asthma who completed the VALIANT trial

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What is this study about?

This study focuses on people with severe asthma, a condition where breathing becomes difficult due to inflammation and narrowing of the airways. The study will test a medication called Verekitug (also known as UPB-101), which is given as an injection under the skin. This medicine is a type of monoclonal antibody, which is a protein designed to target specific substances in the body that contribute to asthma symptoms.

The purpose of this research is to evaluate the safety and effectiveness of long-term treatment with Verekitug in adults who have previously participated in another study called VALIANT. During the study, participants will receive either Verekitug or a placebo as an injection under the skin for approximately 60 weeks. The study will monitor how well participants’ asthma is controlled and how their breathing functions over time.

Throughout the study, participants will have regular check-ups that include breathing tests, blood samples, and questionnaires about their asthma symptoms. The study will track how often participants experience asthma flare-ups that require treatment with steroids. Blood samples will be collected to measure the amount of medicine in the body and to check for the body’s immune response to the treatment.

1 Initial study visit

During the first visit, after completing the VALIANT study, you will undergo initial assessments including physical examination, laboratory tests, vital signs measurement, and ECG (heart rhythm test).

Your ability to forcefully exhale air in 1 second will be measured, along with the amount of nitric oxide in your breath to check airway inflammation.

You will complete a questionnaire about your asthma symptoms and treatment.

2 Treatment administration

Verekitug will be administered through subcutaneous injection (under the skin).

Blood samples will be collected to measure the amount of medication in your system.

Your blood will also be tested for antibodies against the medication.

3 Ongoing monitoring

Regular visits will occur throughout the 60-week treatment period.

During each visit, you will undergo physical examinations, laboratory tests, vital signs measurements, and ECGs.

Any severe asthma attacks requiring steroid treatment will be recorded.

Your breathing capacity and exhaled nitric oxide levels will be measured regularly.

You will complete questionnaires about your asthma management.

4 Safety monitoring

Throughout the study, you will be monitored for any side effects.

Any changes in your health will be documented and assessed.

Regular blood tests will continue to check medication levels and antibody development.

5 Study completion

Final assessments will include physical examination, laboratory tests, and breathing measurements.

A final questionnaire about your asthma management will be completed.

The study will conclude with a final evaluation of your overall health status.

Who Can Join the Study?

  • Must have completed the VALIANT study according to protocol, without meeting any discontinuation criteria and attended the final study visit
  • Must be an adult (18 years or older)
  • Must sign and receive a copy of the approved informed consent form (a document that explains the study details and patient rights)
  • Must agree to use appropriate contraception methods as required by local regulations while participating in the study
  • Can be either male or female
  • Must have been diagnosed with severe asthma (a condition where breathing is significantly impaired and regular asthma medications may not provide adequate control)

Who Cannot Join the Study?

  • Previous severe allergic reactions to similar medications (causing difficulty breathing, severe rash, or requiring emergency treatment)
  • Currently participating in other clinical trials or within 30 days of the last study
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Severe heart conditions (including heart attack or unstable heart disease)
  • Lung diseases other than asthma (such as chronic bronchitis or emphysema)
  • Serious liver problems or abnormal liver test results
  • Serious kidney problems or abnormal kidney function
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • Current active infections requiring treatment
  • History of drug or alcohol abuse within the past year
  • Pregnant women or women planning to become pregnant during the study
  • Breastfeeding women
  • 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

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Mkyxyid Ckvlle Pxmdictxtfp Layc Sofia Bulgaria
Mdnendv Ckofhb Hbuh Ehxi Sofia Bulgaria
Famnnbcrag Iqaty Pyoyuybqxye Sob Mpsfsh Pavia Italy
Upqhyolenwaarh Czepeoi Kmgvpafki Gdansk Poland
Cxxveuo Mgwkerya Orowqaoeep Mmll Sjg ju Bialystok Poland
Icb Pdglroqzqof Gctl &yqxv Crs Kl Frankfurt Germany
Dujnrqyzphn Azo Ciznzvajsotb Cvxkzx Ctlhie Lzyb Sofia Bulgaria
Mbrrqea Cgvevo Epwspgdzh Ofl Sofia Bulgaria
Mh Ckqdtvcd Rggmxxbvlpk Rfsmnhvb Hezyegf Gect Hamburg Germany
Rwngix Amfsnykt Mjdj Au Pernik Bulgaria
Pohritxu Gutnofx Lgsaldfj Mmgpqqjgro Ppsgzrcekmfb Rzeszcow Poland
Kdrw Gape Bendorf Germany
Mtidron Czrzfe Hsuvzv Rgyo Llwh Ruse Bulgaria
Mqkvuqx Cftlku Zdbulxvj Odp Kozloduy Bulgaria
Otsgzrsuruee Cgnjolz Mfkhoahm Axxm Opysg Cxomxk Kwdlhrzsm Crgrer slcc Ostrowiec Swietokrzyski Poland
Pnep Snxcafv Gktx Leipzig Germany
Clremos Mxiulbpi Aqylttq Bwkylof Kheplolro Cracow Poland
Leuphou Siynjzbfmxk Jx Mricrfbopo I Pnnbcvgwx Wroclaw Poland
Pyweui Sfqvvlday Tdtsmwk sspayg Teplice Czechia
Mwpwxerasyg Cgqtoti Asgjrqunzun Stp z ohnz Cracow Poland
Mghjokb Ctpahy Nti Rcqmmazqfmggri Cpbdou Ejiq Stara Zagora Bulgaria
Gooliyj Issdihuxs Skuzge Barcelona Spain
Eonz Ccheryb Uctcf Mhgkqwmprn Eby Śotrpvi Rzeszow Poland
Awjqvx Nwam Cracow Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.10.2025
Czechia Czechia
Not recruiting
01.10.2025
Germany Germany
Not recruiting
01.10.2025
Italy Italy
Not recruiting
01.10.2025
Poland Poland
Not recruiting
01.10.2025
Spain Spain
Not recruiting
01.10.2025

Trial locations

Verekitug (also known as UPB-101) is a new investigational medication being studied for treating severe asthma in adults. This medication is being tested to understand if it can be used safely over a long period and if it helps control severe asthma symptoms. The study is specifically designed for patients who have already participated in the VALIANT trial and will help researchers understand how well the medication works when used for an extended time.

Investigated Diseases:

Severe Asthma – A chronic respiratory condition characterized by significant inflammation and narrowing of the airways in the lungs. In this form of asthma, the airways are particularly sensitive to triggers, leading to frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The condition involves recurring episodes of airway constriction, mucus production, and inflammation that make breathing difficult. People with severe asthma experience symptoms that are harder to control compared to mild or moderate asthma, with more frequent flare-ups or attacks. The condition often affects daily activities and can worsen at night or early morning.

Trial ID:
2024-519469-23-00
Protocol code:
UPB-CP-05
Trial Phase:
Therapeutic exploratory (Phase II)

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    Bulgaria Czechia Germany Italy Poland Spain