PsoriasisPhase 1NCT04744363
Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)
A Phase 1 study testing Stelara PFS in people with Psoriasis, run by Alvotech Swiss AG at 4 sites in 2 countries.
Trial summary
Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Stelara PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 May 2021to 19 Mar 2022
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Male or female subjects.
- Subjects must be 18 to 55 years old inclusive, at the time of signing the ICF.
- Have a body weight of 60.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive).
- For Japanese subjects only Is a second-generation Japanese person living abroad and both parents and grandparents are of Japanese origin, OR Was born in Japan and both parents and grandparents are of Japanese origin.
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- Medical history without major pathology, according to the PI's judgment.
- Resting supine systolic blood pressure (BP) of ≤140 mm Hg and diastolic BP of ≤90 mm Hg; other vital signs showing no clinically relevant deviations according to the PI's judgment.
- Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI.
- Glycated hemoglobin (HbA1c) ≤42 mmol/mol.
- Clinical safety laboratory results are within the reference ranges or showing no clinically relevant deviations as judged by the PI.
- Have a negative urine drug screen (opiates, methadone, cocaine, amphetamines [including ecstasy and methamphetamines], cannabinoids, barbiturates, and benzodiazepines) and a negative alcohol breath test.
- Tested negative for TB, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc), anti-hepatitis C virus (HCV) antibodies, and anti-human immunodeficiency virus (HIV) 1/2 antibodies at Screening.
- Nonsmoker or occasional smoker, ie, smokes ≤10 cigarettes (or equivalent of tobacco- or nicotine containing products) per week within 3 months of Screening, and ability and willingness to refrain from smoking during confinement at the study site.
- Ability and willingness to abstain from alcohol from 48 hours prior to drug administration, during confinement at the study site until discharge, and 24 hours prior to ambulatory visits.
- Female subjects are eligible to participate if they are not pregnant (see Appendix 3), not breastfeeding, and at least ONE of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP), defined as:
- Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subject's medical records, medical examination, or medical history interview), or Postmenopausal (defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy [HRT]. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient). Female subjects on HRT and whose menopausal status is in doubt will be required to use 1 of the non estrogen hormonal highly effective contraception methods (Appendix 3) from Screening (signing the ICF) until at least 13 weeks after IP administration if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
- Is a WOCBP who agrees to use a highly effective method of contraception (Appendix 3) consistently and correctly from Screening (signing the ICF) until at least 13 weeks after IP administration.
- Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to ONE of the following from Screening (signing the ICF) until at least 13 weeks after IP administration:
- Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- Agree to use a male condom and have their partner use of a contraceptive method with a failure rate of <1% per year as described in Appendix 3 when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile vaginal intercourse or use a male condom during each episode of penile penetration.
- In addition, male subjects must refrain from donating sperm from Screening (signing the ICF) until at least 13 weeks after IP administration.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Have a history of relevant drug and/or food allergies.
- Have a history of hypersensitivity to Stelara, AVT04, or their constituents.
- Have a known history of previous exposure to IL-12 and/or IL-23 inhibitors.
- Have any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (eg, malignancies or demyelinating disorders).
- Presence of chronic obstructive pulmonary disease. Childhood asthma is allowed.
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- Presence of type 1 or 2 diabetes mellitus.
- Have a known history of active or latent TB, except for subjects with documented and complete adequate treatment of TB or initiation (>1 month) of adequate prophylaxis of latent TB, with an isoniazid-based regimen.
- Have resided or traveled in regions where tuberculosis and mycosis are endemic within 90 days before Screening, or who intend to visit such a region during the study period or within 3 months (12 weeks) after dosing.
- Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] based on a positive COVID-19 polymerase chain reaction [PCR] nasopharyngeal swab test), cough or fever, or a history of recurrent or chronic infections.
- Participation in a clinical study with an IP within 60 days or 5 half-lives of that IP (if known), whichever is longer, prior to IP administration in the current study.
- Treatment with nontopical medications (including over-the-counter [OTC] medications and herbal remedies such as St. John's Wort extract) within 7 days or 5 half lives of the drug (whichever is longer) prior to IP administration, with the exception of multivitamins, vitamin C, food supplements and a limited amount of acetaminophen (up to 2 g in 24 hours, but <1 g in 4 hours) or ibuprofen (<1.2 g per day), which may be used throughout the study.
- Have received live vaccines during the past 4 weeks before Screening or have the intention to receive vaccination during the study period or within 13 weeks after dosing.
- Donation of more than 500 mL of blood within 8 weeks prior to drug administration.
- History of alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 mL of beer, 150 mL of wine, or 45 mL of spirits) or drug addiction (including soft drugs like cannabis products).
- Any persons who are:
- An employee of the study site, Investigator, contract research organization (CRO) or Sponsor;
- A first-degree relative of an employee of the study site, the Investigator, CRO, or the Sponsor.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
Nucleus Network
Brisbane
Nucleus Network Melbourne
Melbourne, 3004
About this study
Official title: Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects
Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Read more
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
Read the detailed description
Overall Design:
This study is designed as a FIH, multicenter, randomized, double-blind, 3-arm, parallel-group study of AVT04 compared with EU-approved and US-licensed Stelara when administered as a single 45 mg/0.5 mL SC injection in healthy adult subjects.
Subjects will undertake a Screening visit between Day -28 and Day -1 to determine their eligibility in the study. Subjects who meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1), during which their continued eligibility will be assessed up to Day 1 prior to dosing. On Day 1, eligible subjects will be randomized and will receive a single dose of one of the following: AVT04, US licensed Stelara, or EU approved Stelara.
A staggered sentinel dosing strategy will be implemented as a safety measure, with equal numbers of subjects randomized to each treatment: Sentinel Group 1 (n = 3 subjects [1 per group]), Sentinel Group 2 (n = 6 subjects [2 per group]), and Sentinel Group 3 (n = 9 subjects [3 per group]). Following investigational product (IP) administration, there will be at least 72 hours of close observation and safety monitoring by the Principal Investigator (PI) for each subject and between sentinel groups (ie, 72 hours should have elapsed following IP administration for the last subject in each sentinel group). Provided there are no significant safety or tolerability concerns (or events that meet the study stopping criteria) in the previous sentinel group following a safety review and discussion between the PI, Medical Monitor, and Sponsor, the next sentinel group of subjects will be randomized and dosed. Once the IP dose is deemed to be safe and well tolerated in all 3 sentinel groups, the remaining subjects (n = 276 subjects [92 subjects per group]) will be randomized and dosed.
Sentinel subjects will remain confined to the study site from Day -1 to Day 4 (72 hours postdose); all remaining subjects will be confined to the study site from Day -1 up to Day 2 (24 hours postdose). Following dosing, PK, safety, tolerability, and other assessments will be performed according to the Schedule of Assessments. Subjects will return to the study site on an outpatient basis daily up to Day 12, then once a week from Day 15 to Day 64, followed by once every 2 weeks up to Day 78, and finally on Day 92 for the End-of-Study (EOS) visit.
Number of Subjects:
Approximately 294 healthy subjects (98 per group) are planned to be enrolled at multiple study sites in New Zealand and Australia. Efforts will be made to include at least 10% of subjects (30 subjects, approximately 10 per group) who are of Japanese origin or ethnicity (defined as a second-generation Japanese person living abroad or born in Japan; and both parents and grandparents are of Japanese origin).
A total of 45 subjects (15 per group) are planned to be included in the exploratory ex-vivo biomarker sub study.
Treatment Groups and Duration:
Eligible subjects will be randomly assigned in a 1:1:1 ratio to receive a single 45 mg/0.5 mL SC dose of ustekinumab as AVT04 (test product) or US licensed Stelara or EU approved Stelara (reference products) on Day 1. Randomization will be stratified by ethnicity and body weight at Day -1 as follows: Japanese, non Japanese ≤80 kg, and non-Japanese >80 kg.
The study duration per subject will be approximately 17 weeks. The study will consist of a 4 week Screening period, a 13-week treatment period and assessment period, and an EOS visit on Day 92.
Study Stopping Criteria:
If either of the following scenarios occur, study enrollment and dosing will be halted:
- If >2 subjects experience a suspected unexpected serious adverse reaction (defined as an adverse event [AE] that is serious, unexpected, and considered related to the IP).
- If the Sponsor or Investigator considers there to be an unfavorable benefit-risk ratio based on emerging safety data.
If following consultation between the PI, Medical Monitor, and Sponsor, it is considered appropriate to restart study drug administration in the remaining subjects, justification will be submitted to the Health and Disability Ethics Committee/Human Research Ethics Committee for restarting the study.
- Conditions
- Psoriasis
- Being tested
- Stelara PFS
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stelara PFSDrug
Also called Ustekinumab
Pre filled syringes filled with AVT04 and Stelara
| Study group | Role | What they receive |
|---|---|---|
| AVT04 45 mg SC | Experimental | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen Receives: Drug: Stelara PFS |
| US Stelara 45 mg SC | Active comparator | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen Receives: Drug: Stelara PFS |
| EU Stelara 45 mg SC | Active comparator | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen Receives: Drug: Stelara PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve AUC0-inf
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT04, US Stelara EU Stelara
Measured: From Baseline to day 92
Maximum serum concentration
Venous blood samples will be collected for measurement of serum concentration of AVT04, EU Stelara, US Stelara
Measured: From Baseline to day 92
Secondary outcomes (9)
Ustekinumab serum concentration-time profile following single-dose administration
Venous blood samples will be collected for measurement of serum concentration time profile of AVT04, US-Stelara EU Stelara
Measured: From Baseline to day 92
The secondary PK parameters to be assessed are: AUC0-t
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From Baseline to day 92
Adverse Events
The safety parameters to be assessed include AEs, clinical laboratory assessments (hematology, clinical chemistry, coagulation, urinalysis and urine microscopy), vital signs, ECG, physical examination findings, and injection site reactions
Measured: From screening to day 92
Immunogenicity assessments include ADAs and NAbs
Formation of neutralizing antibodies measured through a validated system
Measured: From screening to day 92
The secondary PK parameters to be assessed are: Tmax
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From screening to day 92
The secondary PK parameters to be assessed are: Kel
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From Screening to day 92
The secondary PK parameters to be assessed are: t1/2
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From Screening to day 92
The secondary PK parameters to be assessed are: Vz/F
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From screening to day 92
The secondary PK parameters to be assessed are: CL/F
Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara
Measured: From Screening to day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start25 May 2021
- Primary completion19 Mar 2022
- Study completion19 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US licensed Stelara® in healthy adult subjects
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Paul Duijzings, MSc, Study director, Program Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744363
- Sponsor's protocol ID
- AVT04-GL-101
- Status last verified
- May 2022
- First submitted
- 16 Dec 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wynne C, Hamilton P, McLendon K, Stroissnig H, Smith M, Duijzings P, Ruffieux R, Otto H, Sattar A, Haliduola HN, Leutz S, Berti F. A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults. Expert Opin Investig Drugs. 2023 May;32(5):417-427. doi: 10.1080/13543784.2023.2215426. Epub 2023 May 23.
PubMed 37212315
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04744363
- Acronym / sponsor ID
- AVT04-GL-101
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 25 May 2021 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 19 Mar 2022 (actual)
- First posted
- 9 Feb 2021 (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.
Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.
Detailed description
Overall Design:
This study is designed as a FIH, multicenter, randomized, double-blind, 3-arm, parallel-group study of AVT04 compared with EU-approved and US-licensed Stelara when administered as a single 45 mg/0.5 mL SC injection in healthy adult subjects.
Subjects will undertake a Screening visit between Day -28 and Day -1 to determine their eligibility in the study. Subjects who meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1), during which their continued eligibility will be assessed up to Day 1 prior to dosing. On Day 1, eligible subjects will be randomized and will receive a single dose of one of the following: AVT04, US licensed Stelara, or EU approved Stelara.
A staggered sentinel dosing strategy will be implemented as a safety measure, with equal numbers of subjects randomized to each treatment: Sentinel Group 1 (n = 3 subjects [1 per group]), Sentinel Group 2 (n = 6 subjects [2 per group]), and Sentinel Group 3 (n = 9 subjects [3 per group]). Following investigational product (IP) administration, there will be at least 72 hours of close observation and safety monitoring by the Principal Investigator (PI) for each subject and between sentinel groups (ie, 72 hours should have elapsed following IP administration for the last subject in each sentinel group). Provided there are no significant safety or tolerability concerns (or events that meet the study stopping criteria) in the previous sentinel group following a safety review and discussion between the PI, Medical Monitor, and Sponsor, the next sentinel group of subjects will be randomized and dosed. Once the IP dose is deemed to be safe and well tolerated in all 3 sentinel groups, the remaining subjects (n = 276 subjects [92 subjects per group]) will be randomized and dosed.
Sentinel subjects will remain confined to the study site from Day -1 to Day 4 (72 hours postdose); all remaining subjects will be confined to the study site from Day -1 up to Day 2 (24 hours postdose). Following dosing, PK, safety, tolerability, and other assessments will be performed according to the Schedule of Assessments. Subjects will return to the study site on an outpatient basis daily up to Day 12, then once a week from Day 15 to Day 64, followed by once every 2 weeks up to Day 78, and finally on Day 92 for the End-of-Study (EOS) visit.
Number of Subjects:
Approximately 294 healthy subjects (98 per group) are planned to be enrolled at multiple study sites in New Zealand and Australia. Efforts will be made to include at least 10% of subjects (30 subjects, approximately 10 per group) who are of Japanese origin or ethnicity (defined as a second-generation Japanese person living abroad or born in Japan; and both parents and grandparents are of Japanese origin).
A total of 45 subjects (15 per group) are planned to be included in the exploratory ex-vivo biomarker sub study.
Treatment Groups and Duration:
Eligible subjects will be randomly assigned in a 1:1:1 ratio to receive a single 45 mg/0.5 mL SC dose of ustekinumab as AVT04 (test product) or US licensed Stelara or EU approved Stelara (reference products) on Day 1. Randomization will be stratified by ethnicity and body weight at Day -1 as follows: Japanese, non Japanese ≤80 kg, and non-Japanese >80 kg.
The study duration per subject will be approximately 17 weeks. The study will consist of a 4 week Screening period, a 13-week treatment period and assessment period, and an EOS visit on Day 92.
Study Stopping Criteria:
If either of the following scenarios occur, study enrollment and dosing will be halted:
- If >2 subjects experience a suspected unexpected serious adverse reaction (defined as an adverse event [AE] that is serious, unexpected, and considered related to the IP).
- If the Sponsor or Investigator considers there to be an unfavorable benefit-risk ratio based on emerging safety data.
If following consultation between the PI, Medical Monitor, and Sponsor, it is considered appropriate to restart study drug administration in the remaining subjects, justification will be submitted to the Health and Disability Ethics Committee/Human Research Ethics Committee for restarting the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US licensed Stelara® in healthy adult subjects
| Arm | Type | Receives |
|---|---|---|
| AVT04 45 mg SC | Experimental | Drug: Stelara PFSSingle dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| US Stelara 45 mg SC | Active comparator | Drug: Stelara PFSSingle dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| EU Stelara 45 mg SC | Active comparator | Drug: Stelara PFSSingle dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Subjects are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Male or female subjects.
- Subjects must be 18 to 55 years old inclusive, at the time of signing the ICF.
- Have a body weight of 60.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive).
Key exclusion criteria (18 listed)
- Subjects are excluded from the study if any of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- Have a history of relevant drug and/or food allergies.
- Have a history of hypersensitivity to Stelara, AVT04, or their constituents.
- Have a known history of previous exposure to IL-12 and/or IL-23 inhibitors.
- Have any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (eg, malignancies or demyelinating disorders).
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 |
|---|---|---|
| Stelara PFSAlso: UstekinumabPre filled syringes filled with AVT04 and Stelara | Drug | AVT04 45 mg SC, EU Stelara 45 mg SC, US Stelara 45 mg SC |
Primary outcome
Area under the plasma concentration-time curve AUC0-inf
Time frame: From Baseline to day 92
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT04, US Stelara EU Stelara
Maximum serum concentration
Time frame: From Baseline to day 92
Venous blood samples will be collected for measurement of serum concentration of AVT04, EU Stelara, US Stelara
9 secondary outcomes
Ustekinumab serum concentration-time profile following single-dose administration
Time frame: From Baseline to day 92
The secondary PK parameters to be assessed are: AUC0-t
Time frame: From Baseline to day 92
Adverse Events
Time frame: From screening to day 92
Immunogenicity assessments include ADAs and NAbs
Time frame: From screening to day 92
The secondary PK parameters to be assessed are: Tmax
Time frame: From screening to day 92
The secondary PK parameters to be assessed are: Kel
Time frame: From Screening to day 92
The secondary PK parameters to be assessed are: t1/2
Time frame: From Screening to day 92
The secondary PK parameters to be assessed are: Vz/F
Time frame: From screening to day 92
The secondary PK parameters to be assessed are: CL/F
Time frame: From Screening to day 92
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 37212315Wynne C, Hamilton P, McLendon K, Stroissnig H, Smith M, Duijzings P, Ruffieux R, Otto H, Sattar A, Haliduola HN, Leutz S, Berti F. A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults. Expert Opin Investig Drugs. 2023 May;32(5):417-427. doi: 10.1080/13543784.2023.2215426. Epub 2023 May 23.
- 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.
Paul Duijzings, MSc study director
Program Lead
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stelara PFS in people with Psoriasis, run by Alvotech Swiss AG at 4 sites in 2 countries.
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 24 inclusion and 18 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: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma concentration-time curve AUC0-inf (time frame: From Baseline to day 92). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744363, which also lists 1 linked publication.
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 23 May 2022.