An Open-label, Single Arm Phase II Study of DFV890 to Assess the Safety, Tolerability and Efficacy in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS) (DFV890-FCAS)

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    6
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 October 2022

Summary

This is an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS.

The study includes a screening period, a treatment period and a follow-up period. At most, the study will last up to 7 months (and up to 13 months for participants with a historical screening cold challenge prior to protocol amendment 04).

Details
Condition Familial Cold Autoinflammatory Syndrome
Treatment DFV890
Clinical Study IdentifierNCT04868968
SponsorNovartis Pharmaceuticals
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent must be obtained before any study-specific assessment is performed
Body mass index within the range of 18-35 kg/m2
Patients with a genetic diagnosis of FCAS
Patients with a clinical history and investigations consistent with FCAS

Exclusion Criteria

Anti-rejection and/or immunomodulatory drugs must be discontinued (please, see protocol for further details)
Clinically significant, suspected active or chronic bacterial (including Mycobacterium tuberculosis), viral or fungal infection within 30 days prior to Day 1
Patients with innate (e.g. TLR immunodeficiencies, defects in IFN-γ signaling) or acquired immune deficiencies (e.g. AIDS)
Presence of human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc), or hepatitis C antibodies at screening
Live vaccines within 4 weeks of Day 1
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they are using highly effective methods of contraception
Other protocol-defined inclusion/exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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