This study is designed as a proof-of-concept to assess if inhibition of IL-1* by canakinumabwill improve lung function in association with attenuation of tissue inflammation in patientswith chronic sarcoidosis, therefore allowing further development…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FVC (forced vital capacity)
Secondary outcome
SUVmax (maximum standardized uptake value) in nodules
Lung function tests
HRCT
6MWT (6-minute walk test) distance
PET scan
Safety and tolerability of ACZ885
Background summary
Chronic sarcoidosis is a systemic disease characterized by development of
granulomas, inflammation and accompanying fibrotic tissue reactions. Although
any organ can be affected, most common disease manifestations are found in
lung, skin, and eye tissues.
IL-1* is known to induce and enhance granuloma formation in vitro and in vivo
and to be involved in associated anergy.Thus, IL-1* represents a potential
therapeutic target for sarcoidosis.
There are no approved therapies for sarcoidosis
Study objective
This study is designed as a proof-of-concept to assess if inhibition of IL-1*
by canakinumab
will improve lung function in association with attenuation of tissue
inflammation in patients
with chronic sarcoidosis, therefore allowing further development of the
compound for treatment of this disease population
Study design
First part: screening, max 40 days
Second part: treatment phase: 24 weeks
Third part: Follow up part; 8 weeks
Intervention
ACZ885 or placebo
Study burden and risks
Study period 9,5 month, 9 visits 2-4 hour
Physical examination: 9 times
Questionnaires:
KSQ (Kings Sarcoidosis Questionnaire), 8 times
FACIT-F (Functional Assessment of Chronic Illness Treatment-Fatigue), 8 times
MMRC (Modified Medical Research Council), twice
Borg Questionnaire: 9 times
Vital signs: 9x
S.c. injections (IMP administration): 12x
Bloodsampling: 9 times, 39 ml per draw, 350 ml total
Urine sampling: 1x
Pregnancy test: 3x (urine 2x, serum 1x)
Lungfunction test: 9x
PET/CT scan twice (fasted)
HRCT/CT scan: twice
ECG: 5 times
6MWT (6-minute walk test): 9 times
Optional:
Pharmcogenetic sub study (6 ml): once
Skin biopt; twice
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
- Disease duration of *1 year
- Clinically active disease demonstated either by a biopsy (any organ) or by bronchoalveolar lavage, patients must also have all of the following criteria:
- MMRC dyspnea scale * 1
- Threshold FVC 50 - 90% of predicted
- Evidence of parenchymal lung involvement by HRCT at screening or by historical radiological evidence
- Male and female subjects ages 18 to 80 years of age weighting at least 50 kg
Exclusion criteria
- Forced vital capacity (FVC) < 50% of predicted
- Any conditions or significant medical problems which in the opinion of the investigator immunocompromises the patient and/ or places the patient at unacceptable risk for immunomodulatory therapy, such as:
- Absolute neutrophil count (ANC) < LLN (1,500/*l)
- Platelets < LLN (75.0 x 109/L)
- Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection
- Presence of human immunodeficiency virus (HIV)infection, active hepatitis B or hepatitis C infections
- Presence of active or latent tuberculosis (TB) established during screening
- Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty*s syndrome
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001255-49-NL |
| ClinicalTrials.gov | NCT02888080 |
| CCMO | NL58131.100.16 |