PsoriasisPhase 1NCT02690142
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-035
A Phase 1 study testing ABY-035 i.v. and ABY-035 s.c. in people with Psoriasis and Healthy Subjects, run by Affibody at 4 sites in United Kingdom.
Trial summary
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Healthy Subjects
- What is being tested?
- ABY-035 i.v. and ABY-035 s.c.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Feb 2016to 10 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A, Part B
- Males or females between 18 and 65 years of age
- Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive. maximum body weight of 120 kg
- In good health, as determined by medical history, physical examination, vital signs assessment, 12 lead electrocardiogram (ECG) and clinical laboratory evaluations.
- Subjects will have given their written informed consent to participate in the study
- In addition for Part C and D
Show all 12Show fewer
- Males or females between 18 and 65 years of age
- Body mass index (BMI) between 18.0 kg/m2 and 39.9 kg/m2, inclusive. Minimum body weight of 45 kg
- Part C: Patients must have had a diagnosis of moderate to severe plaque type psoriasis at least 6 months prior to administration of the study drug without a documented flare within 30 days prior to Screening. Patients with concurrent psoriatic arthritis may be enrolled.
- Part D: Patients must have had a diagnosis of plaque type psoriasis (mild, moderate or severe) at least 6 months prior to administration of the study drug without a documented flare within 30 days prior to Screening. Patients with concurrent psoriatic arthritis may be enrolled.
- Part C: Have plaque type psoriasis covering at least 10% of total body surface area (BSA) at Screening and at Baseline (Day 1) and have a PASI score of 12 or greater at Screening and at Baseline (Day 1).
- Part D: Have at least one psoriatic lesion
Who cannot join
- Part A, Part B, Part C and Part D
- Subjects who have any clinically significant medical history, as determined by the investigator
- Subjects who smoke more than 15 cigarettes, or equivalent, per day
- Alcohol and/or drug abuse
- Positive for HIV, Hepatitis B, Hepatitis C, or tuberculosis
- Subjects who have received a live vaccination within the 3 months prior to Screening
Show all 19Show fewer
- Subjects who are pregnant or lactating
- Subjects who do not agree to use appropriate contraception
- Subjects who have a history of anaphylaxis, drug allergy or clinically significant allergic condition (excluding non active hayfever)
- Participation in another clinical trial
- Subjects who, in the opinion of the investigator, should not participate in this study
- In addition for Part C and D
- Patients who currently have non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
- Patients who have current drug induced psoriasis
- Have any history of any use of or have participated in clinical trials for any therapeutic agent directly targeted to any IL 17 cytokine or receptor
- Have received phototherapy within 4 weeks prior to Day 1
- Patients who have received systemic medications or treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, fumaric acid esters, psoralens, anti TNF (tumour necrosis factor) biologics, anti IL 12/23 biologics, or herbal treatments), within 5 half lives prior to Day 1 (4 weeks for oral anti psoriatics, 12 weeks for psoralens and PUVA (oral psoralen with ultraviolet A), and 24 weeks for biologics)
- Patients who have used topical medications and treatments that could affect psoriasis or PASI evaluation (eg, corticosteroids, coal tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, and trimethyl psoralens) within 2 weeks of administration of IMP (Investigational Medicinal Product)
- Patients who have used any systemic immunosuppressants (eg, methotrexate, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, or tacrolimus) within 8 weeks of administration of IMP (or 5 half lives, whichever is longer).
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Covance Clinical Research Unit Ltd.
Leeds, LS2 9LH
Covance and Royal Liverpool University Hospital Clinical Research Unit
Liverpool, L7 8XP
Imperial Centre for Translational and Experimental Medicine Imperial College Healthcare NHS Trust Hammersmith Hospital
London, W12 0HS
Medicines Evaluation Unit Ltd
Manchester, M23 9QZ
About this study
Official title: A Phase I, Partially-randomised, Partially Double-blinded, Safety, Tolerability and Pharmacokinetic Study of ABY-035 in Healthy Subjects and Psoriasis Patients
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients.
Read the detailed description
This first in human study with ABY-035 (a novel IL-17A inhibitor (interleukin 17A)) consists of four Parts. Part A consists of a single ascending intravenous dose study with 40 healthy volunteers divided into five dose cohorts. Each group consists of 8 subjects where 6 subjects will receive ABY-035 and 2 will receive placebo. The subjects will be followed for pharmacokinetic and safety assessments up to Day 95 after dosing.
Part B of the study consists of 6 healthy volunteers who will be given a single subcutaneous dose of ABY-035. The subjects will follow the same study visit schedule as Part A.
Part C of the study will include up to 12 moderate-to-severe psoriasis patients who each patient will be given a single intravenous dose of ABY-035. The patients will follow the same study visit schedule as Part A and B.
Part D of the study will include up to 18 psoriasis patients (mild, moderate or severe). Each patient will participate in 3 or 7 biweekly dosing occasions of subcutaneously administered ABY-035. Patients will be followed regularly for safety, efficacy and pharmacokinetics for 8 weeks post-final dose.
- Conditions
- Psoriasis, Healthy Subjects
- Being tested
- Placebo, ABY-035 i.v., ABY-035 s.c.
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose i.v.
ABY-035 i.v.Drug
Single dose i.v.
ABY-035 s.c.Drug
Single dose s.c.
| Study group | Role | What they receive |
|---|---|---|
| ABY-035 i.v. | Experimental | Part A: SAD (single ascending dose) including five different dose cohorts. ABY-035 given as intravenous injections. 6 ABY-035 and 2 placebo in each cohort. Receives: Drug: Placebo; Drug: ABY-035 i.v. |
| ABY-035 s.c. | Experimental | Part B: Bioavailability study where 6 subjects will receive ABY-035 as a single subcutaneous injection. Receives: Drug: ABY-035 s.c. |
| ABY-035 i.v. in psoriasis patients | Experimental | Part C: Up to 12 psoriasis patients will receive ABY-035 as a single intravenous injection. Receives: Drug: ABY-035 i.v. |
| ABY-035 s.c. in psoriasis patients | Experimental | Part D: Up to 18 patients will receive 3 or 7 biweekly doses of ABY-035 as s.c. injections Receives: Drug: ABY-035 s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values or other Adverse Events
Safety is monitored by Vital signs, 12-lead ECGs, urinalysis, hematology, clinical chemistry, coagulation, proinflammatory cytokines and CRP
Measured: Follow-up visit (Day 141)
Secondary outcomes (13)
AUC (Area Under the Concentration-time curve) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
t1/2 (half-life) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Maximum serum concentration (Cmax) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Time of maximum observed plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Time of last quantifiable plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Mean Residence Time (MRT) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Total plasma clearance of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Absolute bioavailability (F) of ABY-035 following a single subcutaneous administration in healthy subjects.
After single subcutaneous injection
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 71, Day 95
Time immediately prior to first quantifiable concentration of ABY-035 following a single subcutaneous administration in healthy subjects.
After single subcutaneous injection
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 71, Day 95
Volume of distribution during the terminal elimination phase of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Volume of distribution at steady state of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Measured: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Clinical efficacy of ABY-035, using PASI (Psoriasis Area and Disease Index) response, following single dose intravenous administration in patients with moderate-to-severe psoriasis.
Measured: Screening, Day -1, Day 2, Day 8, Day 15, Day 17, Day 22, Day 29, Day 31, Day 43, Day 71, Day 57, Day 85, Day 95, Day 113, Day 123, Day 141, Day 151
Immunogenicity of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis
Measurement of the occurrence of anti-drug antibodies
Measured: Day -1, Day 1, Day 15, Day 29, Day 57, Day 85, Day 95, Day 113, Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affibody
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Sunu Valasseri, MBBS, MSc, Principal investigator, Covance Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690142
- Sponsor's protocol ID
- ABY-035-001
- Other IDs
- 2015-004531-13, 2015
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klint S, Feldwisch J, Gudmundsdotter L, Dillner Bergstedt K, Gunneriusson E, Hoiden Guthenberg I, Wennborg A, Nyborg AC, Kamboj AP, Peloso PM, Bejker D, Frejd FY. Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis. MAbs. 2023 Jan-Dec;15(1):2209920. doi: 10.1080/19420862.2023.2209920.
PubMed 37184136
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Partially-randomised, Partially Double-blinded, Safety, Tolerability and Pharmacokinetic Study of ABY-035 in Healthy Subjects and Psoriasis Patients
- ClinicalTrials.gov ID
- NCT02690142
- Acronym / sponsor ID
- ABY-035-001
- Conditions
- Psoriasis, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AffibodyIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Feb 2016
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients.
Detailed description
This first in human study with ABY-035 (a novel IL-17A inhibitor (interleukin 17A)) consists of four Parts. Part A consists of a single ascending intravenous dose study with 40 healthy volunteers divided into five dose cohorts. Each group consists of 8 subjects where 6 subjects will receive ABY-035 and 2 will receive placebo. The subjects will be followed for pharmacokinetic and safety assessments up to Day 95 after dosing.
Part B of the study consists of 6 healthy volunteers who will be given a single subcutaneous dose of ABY-035. The subjects will follow the same study visit schedule as Part A.
Part C of the study will include up to 12 moderate-to-severe psoriasis patients who each patient will be given a single intravenous dose of ABY-035. The patients will follow the same study visit schedule as Part A and B.
Part D of the study will include up to 18 psoriasis patients (mild, moderate or severe). Each patient will participate in 3 or 7 biweekly dosing occasions of subcutaneously administered ABY-035. Patients will be followed regularly for safety, efficacy and pharmacokinetics for 8 weeks post-final dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABY-035 i.v. | Experimental | Drug: Placebo, Drug: ABY-035 i.v.Part A: SAD (single ascending dose) including five different dose cohorts. ABY-035 given as intravenous injections. 6 ABY-035 and 2 placebo in each cohort. |
| ABY-035 s.c. | Experimental | Drug: ABY-035 s.c.Part B: Bioavailability study where 6 subjects will receive ABY-035 as a single subcutaneous injection. |
| ABY-035 i.v. in psoriasis patients | Experimental | Drug: ABY-035 i.v.Part C: Up to 12 psoriasis patients will receive ABY-035 as a single intravenous injection. |
| ABY-035 s.c. in psoriasis patients | Experimental | Drug: ABY-035 s.c.Part D: Up to 18 patients will receive 3 or 7 biweekly doses of ABY-035 as s.c. injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Part A, Part B
- Males or females between 18 and 65 years of age
- Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive. maximum body weight of 120 kg
- In good health, as determined by medical history, physical examination, vital signs assessment, 12 lead electrocardiogram (ECG) and clinical laboratory evaluations.
- Subjects will have given their written informed consent to participate in the study
Key exclusion criteria (19 listed)
- Part A, Part B, Part C and Part D
- Subjects who have any clinically significant medical history, as determined by the investigator
- Subjects who smoke more than 15 cigarettes, or equivalent, per day
- Alcohol and/or drug abuse
- Positive for HIV, Hepatitis B, Hepatitis C, or tuberculosis
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 |
|---|---|---|
| PlaceboSingle dose i.v. | Drug | ABY-035 i.v. |
| ABY-035 i.v.Single dose i.v. | Drug | ABY-035 i.v., ABY-035 i.v. in psoriasis patients |
| ABY-035 s.c.Single dose s.c. | Drug | ABY-035 s.c., ABY-035 s.c. in psoriasis patients |
Primary outcome
Number of Participants With Abnormal Laboratory Values or other Adverse Events
Time frame: Follow-up visit (Day 141)
Safety is monitored by Vital signs, 12-lead ECGs, urinalysis, hematology, clinical chemistry, coagulation, proinflammatory cytokines and CRP
13 secondary outcomes
AUC (Area Under the Concentration-time curve) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
t1/2 (half-life) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Maximum serum concentration (Cmax) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Time of maximum observed plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Time of last quantifiable plasma concentration of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Mean Residence Time (MRT) of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Total plasma clearance of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Absolute bioavailability (F) of ABY-035 following a single subcutaneous administration in healthy subjects.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 71, Day 95
Time immediately prior to first quantifiable concentration of ABY-035 following a single subcutaneous administration in healthy subjects.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43, Day 71, Day 95
Volume of distribution during the terminal elimination phase of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Volume of distribution at steady state of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis through analysis of serum samples
Time frame: Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29, Day 30, Day 31, Day 32, Day 43, Day 57, Day 71, Day 85, Day 95, Day 113, Day 141
Clinical efficacy of ABY-035, using PASI (Psoriasis Area and Disease Index) response, following single dose intravenous administration in patients with moderate-to-severe psoriasis.
Time frame: Screening, Day -1, Day 2, Day 8, Day 15, Day 17, Day 22, Day 29, Day 31, Day 43, Day 71, Day 57, Day 85, Day 95, Day 113, Day 123, Day 141, Day 151
Immunogenicity of ABY-035 in healthy subjects and in patients with moderate-to-severe psoriasis
Time frame: Day -1, Day 1, Day 15, Day 29, Day 57, Day 85, Day 95, Day 113, Day 141
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 2 Mar 2018.
- Derived from this study: PubMed 37184136Klint S, Feldwisch J, Gudmundsdotter L, Dillner Bergstedt K, Gunneriusson E, Hoiden Guthenberg I, Wennborg A, Nyborg AC, Kamboj AP, Peloso PM, Bejker D, Frejd FY. Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis. MAbs. 2023 Jan-Dec;15(1):2209920. doi: 10.1080/19420862.2023.2209920.
- 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.
Sunu Valasseri, MBBS, MSc principal investigator
Covance Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABY-035 i.v. and ABY-035 s.c. in people with Psoriasis and Healthy Subjects, run by Affibody at 4 sites in United Kingdom.
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 12 inclusion and 19 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 2 Mar 2018. 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 United Kingdom. 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?
Number of Participants With Abnormal Laboratory Values or other Adverse Events (time frame: Follow-up visit (Day 141)). 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 NCT02690142, 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 2 Mar 2018.