Hereditary Autoinflammatory DiseasePhase 2LANA-FXIINCT04278885
Lanadelumab in FXII-associated Cold Autoinflammatory Syndrome (FACAS)
A Phase 2 study testing Lanadelumab in people with Hereditary Autoinflammatory Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a Phase 2, exploratory, proof-of-concept, single-center, open-label pilot study to assess the effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS). Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Hereditary Autoinflammatory Disease
- What is being tested?
- Lanadelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2020to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents (12 - 17 years) and adults (18 years or older)
- Documented FXII-associated autoinflammatory disorder (FACAS) by positive genetic analysis result
- Clinical symptoms of cold-associated wheals, arthralgia, headache, fatigue (FACAS)
- Able to read, understand and willing to sign the informed consent form and abide with study procedures
- Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as follows:
- Females of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the screening period through 30 days after the final study visit: progestin-only oral contraceptive, condom with or without spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intra-uterine device (IUD, all types). Female participants whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
- Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months do not require contraception during the study.
- Males, including males who are surgically sterile (post vasectomy), with female partners of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from the screening period through 60 days after the last IMP injection.
Who cannot join
- 1. Any other forms of urticaria or angioedema not related to genetic mutations within the FXII gene 2. Concurrent/ongoing treatment with biologics or recent treatment (less than 5 half-lives) 3. Concurrent/ongoing treatment with anakinra within 7 days prior to screening, with canakinumab within 100 days prior to screening 4. Concurrent/ongoing treatment with oral/parenteral corticosteroids greater than 10 mg/d within 2 weeks prior to screening 5. Concurrent/ongoing treatment with other immunosuppressives within 4 weeks or 5 half-lives prior to screening, whichever is longer 6. Treatment with a live (attenuated) virus vaccine within 4 weeks prior to Baseline visit 7. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
- 8. Use of prophylactic therapy with C1-INH, attenuated androgens, or antifibrinolytics within 2 weeks prior to the start of the treatment period (Day 0).
- 9. Any of the following liver function test abnormalities:
- alanine aminotransferase (ALT) > 3x upper limit of normal, or
- aspartate aminotransferase (AST) > 3x upper limit of normal, or
- total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's Syndrome).
Show all 12Show fewer
- 10. Pregnancy or breastfeeding. 11. Subject has any condition that, in the opinion of the Investigator or Sponsor, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results (e.g., history of substance abuse or dependence, a significant pre-existing illness or other major comorbidity that the Investigator considers may confound the interpretation of study results).
- 12. Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial.
- 13. Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial.
- 14. Patients with known hypersensitivity to any constituent of the products of lanadelumab.
- 15. Dementia, altered mental status, or any psychiatric condition, or stay in an institution further to an official or court order that would prohibit the understanding or rendering of informed consent or participation in the study.
- 16. Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factor XII-associated Cold Autoinflammatory Syndrome (FACAS) Linked to Kallikrein-kinin Pathology: Proof of Concept Treatment With Lanadelumab (DX-2930)
This is a Phase 2, exploratory, proof-of-concept, single-center, open-label pilot study to assess the effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS).
Read the detailed description
Factor XII is a serine protease with diverse functions that participates in coagulation, fibrinolysis, complement and contact system activation. So far, mutations in the factor XII gene were linked to the rare coagulation disorder Hagemann factor deficiency and hereditary angioedema (FXII-HAE).
The investigators recently identified a novel FXII mutation in a 4-generation family with profound contact system activation and an autoinflammatory clinical phenotype.
Lanadelumab is a specific kallikrein Inhibitor that is known to prevent clinical symptoms and contact system activation in hereditary angioedema.
This study aims at assessing the clinical effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS).
- Conditions
- Hereditary Autoinflammatory Disease
- Being tested
- Lanadelumab
- Keywords
- FXII-associated cold autoinflammatory syndrome (FACAS)
- Medical subject headings
- Hereditary Autoinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanadelumabDrug
Also called DX-2930
300mg Lanadelumab s.c. administration every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lanadelumab | Experimental | Not described Receives: Drug: Lanadelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported total disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF) grading the severity of 5 key symptoms of FACAS: urticarial rash, fatigue, chills/fever, arthralgia and headache (scale 0=no symptoms to 50=max. of symptoms).
Measured: weeks 9 to 12 compared to weeks -4 to -1 (baseline)
Secondary outcomes (18)
Change in urticarial rash disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported urticarial rash disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF; scale 0=no symptoms to 10=max. of symptoms)
Measured: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in fatigue disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported fatigue disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF; scale 0=no symptoms to 10=max. of symptoms)
Measured: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in chills/fever disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported chills/fever disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF;scale 0=no symptoms to 10=max. of symptoms)
Measured: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in arthralgia disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported arthralgia disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF; scale 0=no symptoms to 10=max. of symptoms)
Measured: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in headache disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Patient-reported headache disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF; scale 0=no symptoms to 10=max. of symptoms)
Measured: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in total disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab Treatment over Long-term use
Patient-reported total disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF; scale 0=no symptoms to 50=max. of symptoms
Measured: weeks 24 to 28 compared to weeks -4 to -1 (baseline)
Change in inflammation markers following lanadelumab Treatment
Assessment of CRP levels
Measured: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Assessment of ESR levels
Measured: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Assessment of SAA levels
Measured: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Assessment of S100 A8/9 levels
Measured: from Baseline to week 12 and week 28
Change in dermatology-specific quality-of-life following lanadelumab Treatment
assessed by Dermatology Life Quality Index (DLQI); scale 0=no impairment to 30=max. impairment
Measured: from Baseline to week 12 and week 28
Changes in generic Health-related quality-of-life
assessed by 36-Item Short Form Health Survey (SF-36); scale 0=max. impairment to 100=no impairment (best Quality of life)
Measured: from Baseline to week 12 and week 28
Incidence of of Treatment-emergent adverse Events, abnormal physical examination, abnormal Routine safety laboratory assessments, abnormal vital signs (safety and tolerability)
Safety of lanadelumab Treatment is assessed by physical examination, routine safety laboratory assessments, vital signs, and adverse Event reporting.
Measured: from Baseline to end of study (week 36 follow-up)
Change in physician global assessment following lanadelumab Treatment as assessed by verbal rating scale
Verbal Rating scale assesses overall Symptoms from 0-10 (0=no symptoms; 10=very severe symptoms)
Measured: from Baseline to week 12 and week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Potential biomarkers include Plasma FXII Levels
Measured: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Potential biomarkers include Plasma prekallikrein Levels
Measured: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Potential biomarkers include Plasma cHMWK Levels
Measured: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Potential biomarkers include IL-1ß release from donor PBMCs
Measured: from Baseline to week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start5 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Autoinflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- exploratory, proof-of-concept, single-center, open-label pilot study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Shire International GmbH
- Responsible party
- Principal investigator, Karoline Krause, Charite University, Berlin, Germany
- Investigators
- Karoline Krause, Prof., Principal investigator, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278885
- Sponsor's protocol ID
- DEALSZ-2019-01
- Acronym
- LANA-FXII
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2020
- Last updated
- 8 Jan 2024
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factor XII-associated Cold Autoinflammatory Syndrome (FACAS) Linked to Kallikrein-kinin Pathology: Proof of Concept Treatment With Lanadelumab (DX-2930)
- ClinicalTrials.gov ID
- NCT04278885
- Acronym / sponsor ID
- LANA-FXII / DEALSZ-2019-01
- Conditions
- Hereditary Autoinflammatory Disease
- Keywords
- FXII-associated cold autoinflammatory syndrome (FACAS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Shire International GmbH
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2020 (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.
This is a Phase 2, exploratory, proof-of-concept, single-center, open-label pilot study to assess the effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS).
Detailed description
Factor XII is a serine protease with diverse functions that participates in coagulation, fibrinolysis, complement and contact system activation. So far, mutations in the factor XII gene were linked to the rare coagulation disorder Hagemann factor deficiency and hereditary angioedema (FXII-HAE).
The investigators recently identified a novel FXII mutation in a 4-generation family with profound contact system activation and an autoinflammatory clinical phenotype.
Lanadelumab is a specific kallikrein Inhibitor that is known to prevent clinical symptoms and contact system activation in hereditary angioedema.
This study aims at assessing the clinical effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- exploratory, proof-of-concept, single-center, open-label pilot study
| Arm | Type | Receives |
|---|---|---|
| Lanadelumab | Experimental | Drug: Lanadelumab |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adolescents (12 - 17 years) and adults (18 years or older)
- Documented FXII-associated autoinflammatory disorder (FACAS) by positive genetic analysis result
- Clinical symptoms of cold-associated wheals, arthralgia, headache, fatigue (FACAS)
- Able to read, understand and willing to sign the informed consent form and abide with study procedures
- Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as follows:
Key exclusion criteria (12 listed)
- 1. Any other forms of urticaria or angioedema not related to genetic mutations within the FXII gene 2. Concurrent/ongoing treatment with biologics or recent treatment (less than 5 half-lives) 3. Concurrent/ongoing treatment with anakinra within 7 days prior to screening, with canakinumab within 100 days prior to screening 4. Concurrent/ongoing treatment with oral/parenteral corticosteroids greater than 10 mg/d within 2 weeks prior to screening 5. Concurrent/ongoing treatment with other immunosuppressives within 4 weeks or 5 half-lives prior to screening, whichever is longer 6. Treatment with a live (attenuated) virus vaccine within 4 weeks prior to Baseline visit 7. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
- 8. Use of prophylactic therapy with C1-INH, attenuated androgens, or antifibrinolytics within 2 weeks prior to the start of the treatment period (Day 0).
- 10. Pregnancy or breastfeeding. 11. Subject has any condition that, in the opinion of the Investigator or Sponsor, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results (e.g., history of substance abuse or dependence, a significant pre-existing illness or other major comorbidity that the Investigator considers may confound the interpretation of study results).
- 12. Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial.
- 13. Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial.
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 |
|---|---|---|
| LanadelumabAlso: DX-2930300mg Lanadelumab s.c. administration every 2 weeks | Drug | Lanadelumab |
Primary outcome
Change in total disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 compared to weeks -4 to -1 (baseline)
Patient-reported total disease activity is assessed by a disease-specific daily health assessment form (FXII-associated Cold autoinflammatory Syndrome daily Health assessment form; FACAS-DHAF) grading the severity of 5 key symptoms of FACAS: urticarial rash, fatigue, chills/fever, arthralgia and headache (scale 0=no symptoms to 50=max. of symptoms).
18 secondary outcomes
Change in urticarial rash disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in fatigue disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in chills/fever disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in arthralgia disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in headache disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment
Time frame: weeks 9 to 12 and weeks 24 to 28, each compared to weeks -4 to -1 (baseline)
Change in total disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab Treatment over Long-term use
Time frame: weeks 24 to 28 compared to weeks -4 to -1 (baseline)
Change in inflammation markers following lanadelumab Treatment
Time frame: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Time frame: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Time frame: from Baseline to week 12 and week 28
Change in inflammation markers following lanadelumab Treatment
Time frame: from Baseline to week 12 and week 28
Change in dermatology-specific quality-of-life following lanadelumab Treatment
Time frame: from Baseline to week 12 and week 28
Changes in generic Health-related quality-of-life
Time frame: from Baseline to week 12 and week 28
Incidence of of Treatment-emergent adverse Events, abnormal physical examination, abnormal Routine safety laboratory assessments, abnormal vital signs (safety and tolerability)
Time frame: from Baseline to end of study (week 36 follow-up)
Change in physician global assessment following lanadelumab Treatment as assessed by verbal rating scale
Time frame: from Baseline to week 12 and week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Time frame: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Time frame: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Time frame: from Baseline to week 28
Changes of plasma levels of potential biomarkers following Lanadelumab treatment
Time frame: from Baseline to week 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Karoline Krause, Prof. principal investigator
Charité University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanadelumab in people with Hereditary Autoinflammatory Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total disease activity score as assessed by daily health assessment form (DHAF) questionnaire following lanadelumab treatment (time frame: weeks 9 to 12 compared to weeks -4 to -1 (baseline)). 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 8 Jan 2024.