Study on Rezpegaldesleukin for Treating Moderate-to-Severe Atopic Dermatitis in Adults

What is this study about?

This clinical trial is focused on studying atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate a treatment called rezpegaldesleukin, also known by its code name NKTR-358. This treatment is given as a solution for injection under the skin. The trial will also use a placebo for comparison purposes.

The purpose of the study is to assess how effective and safe rezpegaldesleukin is for adults with moderate-to-severe atopic dermatitis. Participants in the study will receive either the treatment or a placebo over a period of 54 weeks. The study will monitor changes in the severity of the skin condition and any side effects that may occur.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The study aims to provide valuable information on whether rezpegaldesleukin can be a beneficial treatment option for those suffering from moderate-to-severe atopic dermatitis.

1 Initial Visit and Randomization

Upon joining the study, the patient will attend an initial visit where eligibility is confirmed. This includes a diagnosis of atopic dermatitis for at least 12 months and meeting specific severity criteria.

The patient will be randomly assigned to receive either the study medication, rezpegaldesleukin, or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment is being administered.

2 Treatment Phase

The patient will receive rezpegaldesleukin or placebo through a subcutaneous injection. The medication is administered as a solution for injection.

The treatment will continue for a total of 54 weeks, with regular administration as per the study protocol.

3 Monitoring and Assessments

Throughout the study, the patient will undergo regular assessments to monitor the effectiveness and safety of the treatment. This includes measuring changes in the severity of atopic dermatitis using various scales such as EASI (Eczema Area and Severity Index) and vIGA-AD (Investigator’s Global Assessment for Atopic Dermatitis).

The patient will also be monitored for any adverse events or side effects that may occur during the study period.

4 Follow-Up

After completing the treatment phase, the patient will have follow-up visits to assess the long-term effects of the treatment and to ensure any side effects are managed appropriately.

The study aims to evaluate the mean percent change in EASI from baseline at Week 16 and other secondary outcomes over the 54-week period.

Who Can Join the Study?

Provide written, informed consent to participate in the study and agree to follow the study procedures.
Agree to use highly effective contraceptives during the study.
Be a male or female between 18 and 70 years old on the day of signing the consent form. In some places, the legal age of consent might be higher than 18.
Have a diagnosis of Atopic Dermatitis (AD) for at least 12 months before the first screening visit. AD is a skin condition that causes itchy and inflamed skin.
Meet the following AD severity criteria:
- EASI score of 16 or higher at both screening and randomization visits. EASI is a tool used to measure the severity of eczema.
- vIGA-AD score of 3 or higher at both screening and randomization visits. vIGA-AD is a scale used to assess the overall severity of AD.
- At least 10% of the body surface area (BSA) affected by AD at both screening and randomization visits.
Be a candidate for systemic therapy, which means treatment that affects the entire body, and have a history of not responding well to topical medications (creams or ointments applied to the skin) within 6 months before the first screening visit.
Have a history of not achieving good disease control with topical medications, defined as mild disease or better, after using at least a medium potency topical corticosteroid (TCS) for at least 4 weeks or the maximum recommended duration.
Have a history of significant adverse reactions to TCS, such as skin thinning, allergic reactions, or effects on the whole body, that make further treatment not advisable according to the study doctor.

Who Cannot Join the Study?

Patients who have previously used biologic treatments for their condition cannot participate.
Patients with other skin conditions that might interfere with the study results are not eligible.
Patients with a history of severe allergic reactions to similar medications are excluded.
Patients with certain infections or diseases that could affect the study are not allowed to join.
Pregnant or breastfeeding women cannot take part in the study.
Patients who are currently participating in another clinical trial are not eligible.
Patients with a history of drug or alcohol abuse may be excluded.
Patients with certain medical conditions that could interfere with the study results are not eligible.
Patients who are unable to follow the study procedures or attend study visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Hautarztpraxis Dr. Mihaescu	Augsburg	Germany
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.	Tarnow	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany
Royalderm Agnieszka Nawrocka	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Hospital De Manises	Manises	Spain
Praglandia s.r.o.	Prague	Czechia
Medical Center Hera EOOD	Sofia	Bulgaria
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Pratia Brno s.r.o.	Brno-Stred	Czechia
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Clinical Research Group Sp. z o.o.	Warsaw	Poland
Rosenpark Research GmbH	Darmstadt	Germany
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Asclepius Medical Center OOD	Dupnitsa	Bulgaria
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
NAFTALAN specijalna bolnica za medicinsku rehabilitaciju	Ivanic-Grad	Croatia
ISA Interdisciplinary Study Association GmbH	Berlin	Germany
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
SYNEXUS Magyarorszag Kft.	Budapest	Hungary
UNIMED Medical Center EOOD	Plovdiv	Bulgaria
Hospital General Universitario De Alicante	Alicante	Spain
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Medical Center Excelsior OOD	Sofia	Bulgaria
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Pratia Pardubice a.s.	Pardubice	Czechia
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Synexus Polska Sp. z o.o.	Poznan	Poland
Pratia S.A.	Skorzewo	Poland
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Mfekpalxi Igpowpqmxz Cbkuczxf Skvbfgoa Szr z oyem	Warsaw	Poland
Djsqcngwho Ack Cvqfhrzulg Cbouta Xmkidbixnhin Erog	Sofia	Bulgaria
Uprrjmcdxbxejjfxyqfdy Ansnpvbt	Augsburg	Germany
Cnnvubg Bzklg Kywchsxbist Phhovvwc Sei z olde	Gdansk	Poland
Tmjpavdfkag uoy Sxnnhrmegrh Bkbfgixz Ghqz	Bad Bentheim	Germany
Owrcmya Bhbhw Kgijxytqknj Bv Rfythukb Smh z owcg	Ilawa	Poland
Ppffzodduar Ebohqtkgtqpp	Wroclaw	Poland
Pomzlbkdh Ihmurybx Mtfafraz Meyxemyxwkwu Sfiwl Wdpoguiwijvk I Adqardxhxnzdw	Warsaw	Poland
Gsvgnu Uqayqgvupw Fuzdnyhao	Frankfurt	Germany
Klicehqc dle Ubhiyaopzwbl Myoabkyx Adr	Munich	Germany
Dbboaclbzg Sxg z omjo	Wroclaw	Poland
Mslnbya Csyvtj Mdnmuhzbro Pdixtf Ocd	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.04.2024
Croatia	Not recruiting	30.04.2024
Czechia	Not recruiting	30.04.2024
Germany	Not recruiting	30.04.2024
Hungary	Not recruiting	30.04.2024
Poland	Not recruiting	30.04.2024
Spain	Not recruiting	30.04.2024

Trial locations

Investigated drugs:

Rezpegaldesleukin

Rezpegaldesleukin is a medication being studied for its effectiveness and safety in treating adults with moderate-to-severe atopic dermatitis, a type of skin condition. The trial aims to see how well this medication works in reducing the symptoms of the condition compared to not receiving the active treatment. Rezpegaldesleukin is being tested to understand its potential benefits for patients who have not previously been treated with biologic therapies.

Investigated diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic Dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease tends to flare periodically and then subside. It is associated with a malfunction in the skin barrier, leading to increased sensitivity and susceptibility to irritants and allergens. The condition can cause significant discomfort and may affect sleep and quality of life. Environmental factors, stress, and genetic predisposition can influence its progression.

Trial ID:

2023-507456-69-00

Protocol code:

23-358-05

NCT ID:

NCT06136741

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rezpegaldesleukin for Treating Moderate-to-Severe Atopic Dermatitis in Adults

What is this study about?

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