Cryopyrin Associated Periodic SyndromeICARUSNCT06544018
Circadian Rhythm Deregulation in Patients With CAPS
A study testing Genetic analysis of NLRP3, Circadian rhythm measurement and Saliva sampling in people with Cryopyrin Associated Periodic Syndrome and Familial Cold Urticaria, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within each cell. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cryopyrin Associated Periodic Syndrome, Familial Cold Urticaria, Muckle-Wells Syndrome
- What is being tested?
- Genetic analysis of NLRP3, Circadian rhythm measurement and Saliva sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Feb 2026to 25 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient with CAPS group :
- Patients with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin).
- Patients with sleep apnea syndrome
- Patients working regular night shifts or alternating day and night shifts
- Pregnant or breast-feeding women
- Parents with an infant under 6 months of age
Show all 16Show fewer
- Patient participating in another interventional drug study
- Deprivation of civil rights (curators, guardianship, safeguard of justice)
- Control group (healthy participant):
- Participants with a chronic illness (ALD beneficiaries)
- Participants with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin)
- Participants working regular night shifts or alternating day and night shifts
- Pregnant or breast-feeding women
- Parents with an infant under 6 months of age
- Participant participating in another interventional drug study
- Deprivation of civil rights (curators, guardianship, safeguard of justice)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hôpital Femme-Mère-Enfant (HCL)
Bron, 69677
Alexandre Belot, MD;PhD, 04 27 85 61 26 ext. 33, Alexandre.belot@chu-lyon.fr
Alexandre Belot, MD;PhD
- Not yet recruiting
Hôpital Claude Huriez (CHU de Lille)
Lille, 59037
Éric HACHULLA, MD;PhD, eric.hachulla@chru-lille.fr
Éric HACHULLA, MD;PhD
- Not yet recruiting
Hôpital de la Croix-Rousse (HCL)
Lyon, 69004
Yvan Jamilloux, MD;PhD, yvan.jamilloux@chu-lyon.fr
Yvan Jamilloux, MD;PhD
- Not yet recruiting
Hôpital Edouard Herriot (HCL)
Lyon, 69437
Thomas Barba, MD, thomas.barba@chu-lyon.fr
Thomas Barba, MD
- Not yet recruiting
Hôpital Tenon (AP-HP)
Paris, 75020
Sophie Georgin-Lavialle, MD;PhD, 01 56 01 60 77 ext. 33, sophie.georgin-lavialle@aphp.fr
Sophie Georgin-Lavialle, MD;PhD
- Not yet recruiting
Hôpital Kremlin-Bicêtre (AP-HP)
Paris, 94270
Isabelle Koné-Paut, MD;PhD, 01 45 21 32 46, isabelle.kone-paut@aphp.fr
Isabelle Koné-Paut, MD;PhD
About this study
Official title: Identification of Circadian Rhythm Deregulation in Patients With Cryopyrin-associated Periodic Syndrome (CAPS)
Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within each cell. At the molecular level, the circadian clock is based on a complex system of cell-autonomous transcription loops. These exert positive and negative feedback on themselves, generating cyclic transcriptional activity.
- In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1/CLOCK1 transcriptional activity.. The BMAL1/CLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.)..
- other secondary loops refine the function of the first.
Read more
Recent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA/NOMID syndrome.
Interestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined.
The aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.
- Conditions
- Cryopyrin Associated Periodic Syndrome, Familial Cold Urticaria, Muckle-Wells Syndrome, CINCA Syndrome
- Being tested
- Genetic analysis of NLRP3, Circadian rhythm measurement, Saliva sampling, Questionnaire, AIDAI score
- Keywords
- Circadian clock, cryopyrin-associated periodic syndrome, familial cold urticaria, muckle-wells syndrome, melatonin
- Medical subject headings
- Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysis of NLRP3Genetic
Blood test for genetic analysis of NLRP3
Circadian rhythm measurementDevice
Wear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm
Saliva samplingBiological
Saliva sampling for salivary melatonin determination
QuestionnaireOther
Questionnaire to determine chronotype
AIDAI scoreOther
Disease activity score using AIDAI score (only for patients in the CAPS group) AIDAI : AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX
Blood samplingBiological
- Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18.
- Molecular characterization of circadian clock signaling pathways
| Study group | Role | What they receive |
|---|---|---|
| Patients with cryopyrin-associated periodic syndrome (CAPS) | Active comparator | Confirmed by genetic analysis of NLRP3 Receives: Genetic: Genetic analysis of NLRP3; Device: Circadian rhythm measurement; Biological: Saliva sampling; Other: Questionnaire; Other: AIDAI score; Biological: Blood sampling |
| Control group | Placebo comparator | Healthy participant (absence of CAPS, verified by NLRP3 gene analysis) living in the same household as a CAPS participant included in the protocol Receives: Genetic: Genetic analysis of NLRP3; Device: Circadian rhythm measurement; Biological: Saliva sampling; Other: Questionnaire; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Concentration of the peak secretion of melatonin in both arms
Measured: 6 months after inclusion
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Concentration of the peak secretion of melatonin in both arms
Measured: 12 months after inclusion
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
time of the peak secretion of melatonin in both arms
Measured: 6 months after inclusion
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
time of the peak secretion of melatonin in both arms
Measured: 12 months after inclusion
Secondary outcomes (20)
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Determination of circadian rhythms : amplitude in both arms
Measured: 6 th month
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Determination of circadian rhythms : period in both arms
Measured: 6 th month
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Determination of circadian rhythms : phase in both arms
Measured: 6 th month
Chronotype determination
Number of patients in each chronotype for the 2 arms based on the specific questionnaire in both arm
Measured: 6 th month
sleep duration
sleep duration in both arms
Measured: 6 th month
number of steps
Daily activity in both arms
Measured: 6 th month
Comparison of inflammatory state
basal levels of IL1β in patient monocytes in both arms
Measured: 6 months after inclusion
Comparison of inflammatory state
basal levels of IL1β in patient monocytes in both arms
Measured: 12 months after inclusion
Comparison of inflammatory state
basal levels of IL18 in patient monocytes in both arms
Measured: 6 months after inclusion
Comparison of inflammatory state
basal levels of IL18 in patient monocytes in both arms
Measured: 12 months after inclusion
Disease activity measurement
Number of patient with active disease ie AIDAI (AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX) score >9 in CAPS patient arm
Measured: 6 months after inclusion
Disease activity measurement
Number of patient with active disease ie AIDAI (AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX) score >9 in CAPS patient arm
Measured: 12 months after inclusion
presence or absence of an abnormality in the NLRP3 signalling pathway in CAPS arm compared control arm
Biochemical characterization of the NLRP3 inflammasome protein regulatory pathway in both arms
Measured: 6 months after inclusion
presence or absence of an abnormality in the NLRP3 signalling pathway in CAPS arm compared to control arm
Biochemical characterization of the NLRP3 inflammasome protein regulatory pathway in both arms
Measured: 12 months after inclusion
presence or absence of ASC inflammasome protein regulatory pathway in CAPs arm compared to control arm
Biochemical characterization of the ASC inflammasome protein regulatory pathway in both arms
Measured: 6 months after inclusion
presence or absence of ASC inflammasome protein regulatory pathway in CAPS arm compared to control arm
Biochemical characterization of the ASC inflammasome protein regulatory pathway in both arms
Measured: 12 months after inclusion
presence or absence of the CASPASE-1 inflammasome protein regulatory pathway in CAPS arm compared to control arm
Biochemical characterization of the CASPASE-1 inflammasome protein regulatory pathway in both arms
Measured: 6 months after inclusion
presence or absence of the CASPASE-1 inflammasome protein regulatory pathway in CAPS arm compared to control arm
Biochemical characterization of the CASPASE-1 inflammasome protein regulatory pathway in both arms
Measured: 12 months after inclusion
presence or absence of REV-ERBα inflammasome protein regulatory pathway in CAPS arm compared to control arm
Biochemical characterization of the REV-ERBα inflammasome protein regulatory pathway in both arms
Measured: 6 months after inclusion
presence or absence of REV-ERBα inflammasome protein regulatory pathway in CAPS arm compared to control arm
Biochemical characterization of the REV-ERBα inflammasome protein regulatory pathway in both arms
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start25 Feb 2026
- Primary completion25 Feb 2029 (estimated)
- Study completion25 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryopyrin Associated Periodic SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, interventional, comparative, open-label, controlled study with 2 parallel arms.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544018
- Sponsor's protocol ID
- 69HCL23_0417
- Other IDs
- 2023-A01088-37
- Acronym
- ICARUS
- Status last verified
- Feb 2026
- First submitted
- 7 May 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Circadian Rhythm Deregulation in Patients With Cryopyrin-associated Periodic Syndrome (CAPS)
- ClinicalTrials.gov ID
- NCT06544018
- Acronym / sponsor ID
- ICARUS / 69HCL23_0417
- Conditions
- Cryopyrin Associated Periodic Syndrome, Familial Cold Urticaria, Muckle-Wells Syndrome, CINCA Syndrome
- Keywords
- Circadian clock, cryopyrin-associated periodic syndrome, familial cold urticaria, muckle-wells syndrome, melatonin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Feb 2029 (estimated)
- Study completion
- 25 Feb 2029 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within each cell. At the molecular level, the circadian clock is based on a complex system of cell-autonomous transcription loops. These exert positive and negative feedback on themselves, generating cyclic transcriptional activity.
- In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1/CLOCK1 transcriptional activity.. The BMAL1/CLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.)..
- other secondary loops refine the function of the first.
Recent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA/NOMID syndrome.
Interestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined.
The aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, interventional, comparative, open-label, controlled study with 2 parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Patients with cryopyrin-associated periodic syndrome (CAPS) | Active comparator | Genetic: Genetic analysis of NLRP3, Device: Circadian rhythm measurement, Biological: Saliva sampling, Other: Questionnaire, Other: AIDAI score, Biological: Blood samplingConfirmed by genetic analysis of NLRP3 |
| Control group | Placebo comparator | Genetic: Genetic analysis of NLRP3, Device: Circadian rhythm measurement, Biological: Saliva sampling, Other: Questionnaire, Biological: Blood samplingHealthy participant (absence of CAPS, verified by NLRP3 gene analysis) living in the same household as a CAPS participant included in the protocol |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Patients with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin).
- Patients with sleep apnea syndrome
- Patients working regular night shifts or alternating day and night shifts
- Pregnant or breast-feeding women
- Parents with an infant under 6 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic analysis of NLRP3Blood test for genetic analysis of NLRP3 | Genetic | Control group, Patients with cryopyrin-associated periodic syndrome (CAPS) |
| Circadian rhythm measurementWear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm | Device | Control group, Patients with cryopyrin-associated periodic syndrome (CAPS) |
| Saliva samplingSaliva sampling for salivary melatonin determination | Biological | Control group, Patients with cryopyrin-associated periodic syndrome (CAPS) |
| QuestionnaireQuestionnaire to determine chronotype | Other | Control group, Patients with cryopyrin-associated periodic syndrome (CAPS) |
| AIDAI scoreDisease activity score using AIDAI score (only for patients in the CAPS group) AIDAI : AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX | Other | Patients with cryopyrin-associated periodic syndrome (CAPS) |
| Blood sampling1. Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18. 2. Molecular characterization of circadian clock signaling pathways | Biological | Control group, Patients with cryopyrin-associated periodic syndrome (CAPS) |
Primary outcome
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Time frame: 6 months after inclusion
Concentration of the peak secretion of melatonin in both arms
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Time frame: 12 months after inclusion
Concentration of the peak secretion of melatonin in both arms
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Time frame: 6 months after inclusion
time of the peak secretion of melatonin in both arms
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3,
Time frame: 12 months after inclusion
time of the peak secretion of melatonin in both arms
20 secondary outcomes
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Time frame: 6 th month
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Time frame: 6 th month
Difference in circadian clock biomarkers between patients and control participants for Circadian Rhythm Characteristics.
Time frame: 6 th month
Chronotype determination
Time frame: 6 th month
sleep duration
Time frame: 6 th month
number of steps
Time frame: 6 th month
Comparison of inflammatory state
Time frame: 6 months after inclusion
Comparison of inflammatory state
Time frame: 12 months after inclusion
Comparison of inflammatory state
Time frame: 6 months after inclusion
Comparison of inflammatory state
Time frame: 12 months after inclusion
Disease activity measurement
Time frame: 6 months after inclusion
Disease activity measurement
Time frame: 12 months after inclusion
presence or absence of an abnormality in the NLRP3 signalling pathway in CAPS arm compared control arm
Time frame: 6 months after inclusion
presence or absence of an abnormality in the NLRP3 signalling pathway in CAPS arm compared to control arm
Time frame: 12 months after inclusion
presence or absence of ASC inflammasome protein regulatory pathway in CAPs arm compared to control arm
Time frame: 6 months after inclusion
presence or absence of ASC inflammasome protein regulatory pathway in CAPS arm compared to control arm
Time frame: 12 months after inclusion
presence or absence of the CASPASE-1 inflammasome protein regulatory pathway in CAPS arm compared to control arm
Time frame: 6 months after inclusion
presence or absence of the CASPASE-1 inflammasome protein regulatory pathway in CAPS arm compared to control arm
Time frame: 12 months after inclusion
presence or absence of REV-ERBα inflammasome protein regulatory pathway in CAPS arm compared to control arm
Time frame: 6 months after inclusion
presence or absence of REV-ERBα inflammasome protein regulatory pathway in CAPS arm compared to control arm
Time frame: 12 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Cryopyrin Associated Periodic Syndrome
RecruitingObservational study
Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)
NOMID, DIRA
RecruitingObservational study
Ilaris NIS in Korea
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
RecruitingPhase 1
Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure Changes in Organ-Specific Amyloid Load
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic analysis of NLRP3, Circadian rhythm measurement and Saliva sampling in people with Cryopyrin Associated Periodic Syndrome and Familial Cold Urticaria, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Alexandre, PR (04 27 85 61 26 ext. 33, Alexandre.belot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of circadian rhythm deregulation in patients with cryopyrinopathy (CAPS) whose diagnosis was confirmed by genetic analysis of NLRP3, (time frame: 6 months after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.