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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05331300
Registration number
NCT05331300
Ethics application status
Date submitted
16/03/2022
Date registered
15/04/2022
Date last updated
29/04/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease
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Scientific title
A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease
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Secondary ID [1]
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LASN01-CL-1101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis
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Thyroid Eye Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Eye
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Diseases / disorders of the eye
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Inflammatory and Immune System
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Autoimmune diseases
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Metabolic and Endocrine
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Other endocrine disorders
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LASN01
Treatment: Drugs - LASN01
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Experimental: LASN01 - Parts A and B [Healthy Volunteers] - Completed/Closed to enrollment
Placebo Comparator: Placebo - Parts A and B [Healthy Volunteers] - Completed/Closed to enrollment
Experimental: LASN01 - Part C [Pulmonary Fibrosis] - Open to enrollment
Placebo Comparator: Placebo - Part C [Pulmonary Fibrosis] - Open to enrollment
Experimental: LASN01 - Part D [Thyroid Eye Disease] - Open to enrollment
Placebo Comparator: Placebo - Part D [Thyroid Eye Disease] - Open to enrollment
Treatment: Drugs: LASN01
Escalating single and multiple doses of LASN01
Treatment: Drugs: LASN01
LASN01 will be administered intravenously
Treatment: Drugs: Placebo
Escalating doses of matching placebo
Treatment: Drugs: Placebo
Placebo will be administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment emergent, treatment related, and serious adverse events
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Assessment method [1]
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Timepoint [1]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Primary outcome [2]
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Changes in concomitant medications
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Assessment method [2]
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Timepoint [2]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Primary outcome [3]
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Changes from Baseline in clinical laboratory evaluations following study drug administration
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Assessment method [3]
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Timepoint [3]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Primary outcome [4]
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Changes from Baseline in vital signs following study drug administration
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Assessment method [4]
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Timepoint [4]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Primary outcome [5]
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Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration
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Assessment method [5]
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Timepoint [5]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Primary outcome [6]
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Changes from Baseline in physical examination (PE) results following study drug administration
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Assessment method [6]
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Timepoint [6]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
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Secondary outcome [1]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [2]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (T max)
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Assessment method [2]
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Timepoint [2]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [3]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
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Assessment method [3]
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Timepoint [3]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [4]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
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Assessment method [4]
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Timepoint [4]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [5]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
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Assessment method [5]
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Timepoint [5]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [6]
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PK parameter assessed by serum LASN01 concentration at specified timepoints for half life ( t1/2).
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Assessment method [6]
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Timepoint [6]
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Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
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Secondary outcome [7]
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Percentage of patients with a =2 mm reduction from Baseline in proptosis in the study eye, (LASN01 versus placebo) without deterioration [=2 mm increase] of proptosis in the fellow eye at Week 29
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Assessment method [7]
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Timepoint [7]
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Week 1-Week 29 in Part D
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Secondary outcome [8]
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Mean change from baseline in proptosis of LASN01 patients versus placebo patients
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Assessment method [8]
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Timepoint [8]
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Day 1- Day 365 in Part D
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Eligibility
Key inclusion criteria
I. Participant Inclusion Criteria-
Parts A, B, C, and D
1. Female participants must be nonpregnant, nonlactating, and either postmenopausal for
=12 months, surgically sterile for =6 months, or agree to use 2 effective methods of
contraception or a highly effective method of contraception. Males must be surgically
sterile for =6 months or agree to highly effective methods of contraception.
2. Able to comprehend and willing to sign an ICF and understand and comply with the
requirements of the study.
Part A and Part B only
3. Males or females, 18 through 60 years of age, inclusive
4. Body weight =110 pounds (=50 kg); body mass index (BMI) within the range of 18 through
32.0 kg/m2
5. In good health as determined by the Investigator
Part C only
6. Male and female patients >40 years of age (IPF patients) or =21 years of age (PF-ILD
patients)
IPF-specific
7. A diagnosis of IPF
8. IPF has been stable for =3 months at Screening
PF-ILD-specific
9. Patients with physician diagnosed ILD who fulfill =1 of the following criteria for
PF-ILD within 24 months of the Screening visit despite treatment with approved and/or
unapproved medications used in clinical practice to treat ILD.
10. Fibrosing lung disease on HRCT performed within 3 years of the Screening Visit
11. For patients with underlying CTD: stable CTD as defined by no initiation of new
therapy or withdrawal of therapy for CTD within 6 weeks before the Screening visit
12. FVC =45% predicted
Part D only
13. Male or female patients of age =18 years
14. Clinical diagnosis of Graves' disease associated with active TED
15. Moderate-to-severe active TED
16. Less than 15 months from onset of TED in the study eye
17. No previous medical treatment for TED with the exception of local supportive measures,
mycophenolate and oral or injectable steroids, immunomodulating therapies, and/or
orbital irradiation/radiotherapy
II. Participant
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria
Parts A, B, C, and D
1. Any acute or chronic condition that would limit the participant's ability to
participate in and complete this clinical study
Part A and Part B only
2. Significant history or clinical manifestation of any significant endocrine, metabolic,
allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder
3. History of significant hypersensitivity; intolerance; or allergy to any drug compound,
food, or other substance; or history of anaphylaxis or angioedema
4. Positive serum test for HIV or hepatitis infection
5. Currently receiving any antibiotics for upper or lower respiratory tract infections
6. Use of any prescription drug or vaccine within 21 days before Check-in with the
exception of hormonal contraceptives and vaccines.
7. Any prescription biologic within 3 months or 5 half-lives (whichever is greater)
before Check-in
8. Participation in any other investigational study drug trial in which an
investigational study drug was administered within 30 days before randomization or an
investigational biological study drug was administered within 3 months before Check-in
Part C only
9. History of clinically relevant cardiovascular disease that could jeopardize a
patient's health during the course of the study
10. Patients with concurrent active malignancy other than adequately treated basal cell
carcinoma of the skin or carcinoma in situ of the cervix
IPF-specific
11. FVC <45% predicted of normal or a forced expiratory volume during the first second of
the forced breath (FEV1)/FVC ratio of <0.7
12. Extent of emphysema in the lungs exceeds fibrosis
13. Currently receiving pirfenidone or nintedanib if on treatment for <3 consecutive
months or needed dose modification due to AEs in the last 3 months
PF-ILD-specific
14. Diagnosis of IPF
15. Diagnosis of sarcoidosis
16. Significant pulmonary arterial hypertension
17. FVC <45% predicted of normal or a FEV1/FVC ratio of <0.7
18. Previous treatment with pirfenidone
Part D only
19. Any previous use of anti-insulin-like growth factor 1 receptor monoclonal antibody
(eg, teprotumumab) at any time
20. Patients with 2 mm proptosis decrease between Screening and Baseline, or a 1-point
decrease on the CAS 7-point scale in any 2 weeks during the Screening period
21. Patients with decreased best corrected visual acuity due to optic neuropathy, new
visual field defect, or color defect secondary to optic nerve involvement within the
last 6 months before Screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Site AU07 - Botany
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Recruitment hospital [2]
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Site AU05 - Hurstville
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Recruitment hospital [3]
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Site AU03 - Brisbane
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Recruitment hospital [4]
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Site AU06 - Camberwell
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Recruitment hospital [5]
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Site AU01 - Melbourne
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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2220 - Hurstville
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Recruitment postcode(s) [3]
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4006 - Brisbane
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment postcode(s) [5]
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3220 - Melbourne
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Sha Tin
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Country [3]
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New Zealand
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State/province [3]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Lassen Therapeutics 1 PTY LTD
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
LASN01 is a novel, fully human antibody directed against the human IL-11 receptor that is
being developed to address the fibro-inflammatory pathology of pulmonary fibrosis and TED.
This study is a four-part trial consisting of Parts A, B, C and D.
The primary objective of this study is to evaluate the safety and tolerability of LASN01, and
the secondary objective is to evaluate the preliminary efficacy, immunogenicity, and
pharmacokinetics of single and multiple doses of LASN01 in healthy participants and in
patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrosing interstitial lung
disease (PF-ILD) or Thyroid Eye disease (TED).
Please note that the Phase 1 (single and multiple ascending dose, SAD/MAD) portion in healthy
subjects is completed and the Phase 2a portion in patients is actively recruiting.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05331300
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lassen Therapeutics
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Address
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Country
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Phone
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+1 858 251-7528
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05331300
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