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NCT06878365 · ClinicalTrials.gov registry record · Phase 1

A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies

A Phase 1 study of Type 1 Interferonopathies, sponsored by Boehringer Ingelheim.

Active
Registry status
Phase 1
Development phase
16
Enrollment target
20
Study locations

NCT06878365 is a Phase 1 study of Type 1 Interferonopathies that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 16 participants. The trial reports 20 study locations across 4 states.

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The verdict

NCT06878365, a Phase 1 study of Type 1 Interferonopathies, is active but no longer recruiting, sponsored by Boehringer Ingelheim.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults with selected type 1 interferonopathies. People can join the study if they have Aicardi-Goutières syndrome (AGS), Coatomer subunit alpha (COPA) syndrome, Familial chilblain lupus (FCL), or another type 1 interferonopathy with a specific gene mutation. The purpose of this study is to find out how BI 3000202 is tolerated in people with selected type 1 interferonopathies. Participants take a lower dose of BI 3000202 as tablets for 4 weeks. Afterwards, they take a higher dose of BI 3000202 as tablets for 36 weeks. They may continue with the study treatment until every participant has completed 40 weeks of treatment (about 9 months). The participants may also continue their regular treatment for their condition during the study. During this study, participants visit the study site 13 times or more, depending on when they start their participation. The doctors check the health of the participants and note any health problems that could have been caused by BI 3000202.

Conditions Studied

Interventions

  • DRUG BI 3000202_low dose
  • DRUG BI 3000202_high dose

Study Locations (20)

Other

  • Universitair Ziekenhuis Gent - Ghent
  • HOP Gui de Chauliac - Montpellier
  • Hôpital Necker - Paris
  • HOP Tenon - Paris
  • Universitätsklinikum Carl Gustav Carus Dresden - Dresden
  • Medizinische Hochschule Hannover - Hanover
  • Universitätsklinikum Tübingen - Tübingen
  • Barzilai Medical Center - Ashkelon
  • ASST degli Spedali Civili di Brescia - Brescia
  • Azienda Sanitaria Universitaria Giuliano Isontina - Trieste
  • ULS de Santa Maria, E.P.E - Lisbon
  • ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António - Porto
  • Hospital Universitari Vall D Hebron - Barcelona
  • Hospital Universitario La Paz - Madrid
  • Hospital Virgen del Rocío - Seville
  • Royal Infirmary of Edinburgh - Edinburgh
  • Royal Free Hospital - London

California

  • University of California San Francisco - San Francisco

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2025-07-29
Est. Completion 2026-12-07
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT06878365

The ClinicalTrials.gov registry entry for NCT06878365 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Interferonopathies appearing as the primary indexed condition, and to 2 interventions - of which BI 3000202_low dose is the first listed.

NCT06878365 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06878365 about?

NCT06878365 is a clinical study titled "A Study to Test How Well BI 3000202 is Tolerated by People With Type 1 Interferonopathies". This study is open to adults with selected type 1 interferonopathies. People can join the study if they have Aicardi-Goutières syndrome (AGS), Coatomer subunit alpha (COPA) syndrome, Familial chilblain lupus (FCL), or another type 1 interferonopathy with a specific gene mutation. The purpose of thi...

What is the current status of trial NCT06878365?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-07-29. Estimated completion is 2026-12-07.

What conditions does trial NCT06878365 study?

This clinical trial studies the following conditions: Type 1 Interferonopathies.

What interventions are being tested in trial NCT06878365?

The interventions under investigation include: BI 3000202_low dose (DRUG), BI 3000202_high dose (DRUG).

Who is sponsoring clinical trial NCT06878365?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06878365 being conducted?

This trial has 20 study locations across California, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.