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Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia | Clinical Trials | Clareo Health

RECRUITING

Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia

Clinical and Demographic Characteristics of Adult Patients With NEurofibromatosis in RUSsia

NCT07088991•AstraZeneca

View on ClinicalTrials.gov

Summary

Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)

Detailed Description

Open-label single-arm, non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years at the time of inclusion.
•2. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study.
•3. NF1 diagnosed (according to the international consensus criteria for evaluating NF1 \[18\]), see Appendix A.
•4. Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographic findings).
•5. Existing of PN-associated symptoms.
•6. Adult patients (≥18 years) with newly diagnosed PN or established PN naïve to MEK-inhibitor therapy verified by medical records/histories (e.g., prior prescriptions, hospitalization data).

Exclusion Criteria

•1. The participation in any clinical study currently (patients participating in other non-interventional studies may be included);
•2. Patients with the evidence of a malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.
•3. In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies.
•4. Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial, if they are unable to undergo radiographic evaluations or MRI scans requested for research purposes, or other studies which might negatively impact on the pregnancy.
•5. Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screening or initiation of therapy prior to age 18 verified by medical records/histories (e.g., prior prescriptions, hospitalization data).
•6. Patients who modify their index pathogenetic therapy regimen during the study (for example, pathogenetic antitumor therapy of PN; switching to a different therapy), as determined by the investigator at any protocol-specified visit during the a study, will be excluded from the primary efficacy analysis population from the point of modification onward and will not continue study participation.

Locations (11)

Research Site

Arkhangelsk, Russia

Research Site

Chelyabinsk, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Moscow, Russia

Research Site

Nizhny Novgorod, Russia

Research Site

Novosibirsk, Russia

Research Site

Saint-Peretsburg, Russia

Research Site

Samara, Russia

Research Site

Tomsk, Russia

Research Site

Ufa, Russia

Key Dates

Start Date

June 6, 2025

Primary Completion Date

March 31, 2028

Completion Date

March 31, 2028

Last Updated

February 19, 2026

Enrollment

200

ESTIMATED participants

Conditions

Neurofibromatosis

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1

NCT06541847

Neurofibromatosis Type 1

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NCT07221331

Neurofibromatosis Type 1

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A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia

Inclusion Criteria

Exclusion Criteria

A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1

Prevalence, Clinical Characteristics, Progression, and Management of Neurofibromatosis Type 1 in Egypt (NF1-Egy)

A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)

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