Moderate to Severe Plaque PsoriasisPhase 3BCD-085-7NCT03390101
An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing BCD-085 Q2W and BCD-085 Q4W in people with Moderate to Severe Plaque Psoriasis, run by Biocad at 1 site in Russia.
Trial summary
BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- BCD-085 Q2W and BCD-085 Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteRussia
- Study dates
- 26 Dec 2017to 20 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must give a written and signed informed consent.
- Men or women at least 18 years old at the time of signing the ICF
- Moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form.
- Patients received at least one course of phototherapy or systemic therapy for psoriasis or are candidates for such treatment according to the investigator.
- Body surface area (BSA) affected by psoriasis of 10% or greater, the PASI score of 10 or greater, and the sPGA score of 3 or greater at screening.
- Negative pregnancy urine test in female subjects (no test is required in women who are post-menopausal for at least 2 years and in surgically sterile women).
- The patient must be able to follow the Protocol procedures (in the investigator's opinion).
- Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent to 20 weeks after the last dose of the study therapy. This requirement does not apply to the patients after surgical sterilization and to females who are post-menopausal for 2 years or longer. Reliable contraception methods suggest using one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives
Who cannot join
- Baseline erythrodermic, pustular, and guttate psoriasis or any other skin diseases (e.g. eczema) that can affect/complicate assessment of psoriasis treatment
- Use of the following medications:
- Prior use of monoclonal antibodies targeting IL17 or its receptor
- Prior use of more than one drug containing monoclonal antibodies or their fragments
- Prior use of monoclonal antibodies within 12 weeks before signing the informed consent.
- Any systemic medications for psoriasis (including glucocorticoids, methotrexate, sulfasalazine, cyclosporine, acitretin, mycophenolate mofetil, аpremilast, calcitriol derivatives, etc.) used within 4 weeks before signing the ICF If prior systemic therapy with non-biologics was stopped due to any reasons, the screening period can be extended up to 8 weeks during which no new non-biologics are allowed.
Show all 45Show fewer
- Use of phototherapy within 4 weeks before signing the ICF
- Topical medications for psoriasis used within 2 weeks before signing the ICF
- Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF
- Any active systemic infection or recurrent infection at screening/randomization
- HIV, hepatitis B, hepatitis C, or syphilis
- Blood biochemistry abnormalities appearing as:
- baseline creatinine > 2 × ULN
- baseline ALT, AST or alkaline phosphatase > 2.5 × ULN
- baseline bilirubin > 1.5 × ULN
- WBC count < 3.0 × 109/L; ANC < <2.0× 109/L; platelet count < 100 × 109/L, or hemoglobin < 90 g/L at baseline
- Any psychiatric conditions including severe depressive disorders and/or any history of suicidal thoughts or suicidal attempts ;
- Signs of clinically significant depression (Beck's score of 16 or more at screening)
- Alcohol or substance abuse
- Tuberculosis now or in the past
- Latent TB infection (positive results of the Diaskintest or QuantiFERON test, or T-spot).
- Concurrent diseases ongoing at screening that may increase the risk of adverse events during the study or affect the evaluation of psoriasis symptoms (mask, enhance or alter the symptoms of psoriasis, or cause clinical or laboratory signs/symptoms similar to those of psoriasis):
- active inflammatory diseases or aggravation of chronic inflammatory diseases other than psoriasis
- Stable angina class III-IV, unstable angina or a history of myocardial infarction within 1 year before signing the informed consent
- Cardiac failure moderate to severe (NYHA class III-IV)
- Treatment-resistant hypertension
- A history of severe asthma or angioedema
- Moderate to severe respiratory failure, COPD grade ¾
- Diabetes mellitus with unsatisfactory glycemic control, when the level of glycated hemoglobin HbA1С ≥8% (results are valid if the test was performed at the screening or within 3 months before signing the ICF)
- The patient has thyrotoxicosis, which persists in the presence of thyreostatic medications, or hypothyroidism despite of the thyroid hormone treatment
- Systemic autoimmune diseases (including but not limited to SLE, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease , intersection syndrome, etc.)
- Any other underlying conditions (including but not limited to metabolic, hematologic, hepatic, renal, pulmonary, neurological, endocrine, cardiac, gastrointestinal conditions and infections) that, in the opinion of the investigator, may affect the course of psoriasis, affect the assessment of signs/symptoms of psoriasis, or put patients using the study treatment at additional risk
- Malignancies with less than 5 years of remission
- Known severe allergies (anaphylaxis or drug allergy to two or more drug products)
- Known allergy or intolerance to monoclonal antibody drugs (murine, chimeric, humanized, or human) or any other components of the test drug or comparator
- Major surgery within 30 days before the screening, or a major surgery being scheduled at any time during the study
- Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF
- Systemic antibacterial/antimycotic/antiprotozoal treatment within 2 months before the signing the ICF
- More than 4 episodes of respiratory infection within 6 months before signing the ICF
- Episodes of severe mycoses (histoplasmosis, coccidioidomycosis, blastomycosis, etc.) within 6 months before signing the ICF
- A history of epileptic attacks or seizures
- Any concurrent diseases during which, in the investigator's opinion, the study treatment can harm the patient
- Pregnancy, breastfeeding, or planning for pregnancy while participating in the study
- Participation in any other clinical study within 3 months before signing the ICF or simultaneous participation in other clinical studies
- Patients will not be re-enrolled in this study if they were randomized to this study and then discontinue the participation
Trial locations and contacts
1 site in 1 country.
About this study
BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for the first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis.
Study purpose:
Read more
To investigate the efficacy and safety of BCD-085 versus placebo in patients with moderate to severe plaque psoriasis (psoriasis vulgaris)
Study objectives:
- To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures.
- To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks.
- 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- BCD-085 Q2W, BCD-085 Q4W, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-085 Q2WDrug
Also called BCD-085
In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.
On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54.
BCD-085 Q4WDrug
Also called BCD-085
In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.
PlaceboDrug
In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.
On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54.
| Study group | Role | What they receive |
|---|---|---|
| BCD-085 Q2W | Experimental | Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.
On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. Receives: Drug: BCD-085 Q2W |
| BCD-085 Q4W | Experimental | Patients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8.
On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. Receives: Drug: BCD-085 Q4W |
| Placebo | Placebo comparator | Patients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10.
On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment
The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease).
Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value) PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start26 Dec 2017
- Primary completion30 Jul 2018
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Plaque 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, Vice-president, R&D, International business development BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390101
- Sponsor's protocol ID
- BCD-085-7
- Acronym
- BCD-085-7
- Status last verified
- May 2022
- First submitted
- 28 Dec 2017
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puig L, Bakulev AL, Kokhan MM, Samtsov AV, Khairutdinov VR, Morozova MA, Zolkin NA, Kuryshev IV, Petrov AN, Artemeva AV, Zinkina-Orikhan AV. Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial. Dermatol Ther (Heidelb). 2021 Aug;11(4):1319-1332. doi: 10.1007/s13555-021-00554-4. Epub 2021 May 31.
PubMed 34060012
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03390101
- Acronym / sponsor ID
- BCD-085-7 / BCD-085-7
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for the first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis.
Study purpose:
To investigate the efficacy and safety of BCD-085 versus placebo in patients with moderate to severe plaque psoriasis (psoriasis vulgaris)
Study objectives:
- To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures.
- To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks.
- 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCD-085 Q2W | Experimental | Drug: BCD-085 Q2WPatients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 1 will be given BCD-085 every 4 weeks through Week 50. |
| BCD-085 Q4W | Experimental | Drug: BCD-085 Q4WPatients in this arm (85 subjects) will receive 120 mg BCD-085 (two SC injections, 60 mg in 1.0 mL each). Thus, the drug will be administered on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2 (induction), Day 1 of Week 6 and Day 1 of Week 10. For the purpose of blind design, patients will receive a placebo (2 injections) on day 1 of week 4 and week 8. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will continue BCD-085 every 4 weeks through Week 50. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this arm (43 subjects) will be given two SC injections of placebo (1.0 mL each) on Day 1 of Week 0, Day 1 of Week 1, Day 1 of Week 2, Day 1 of Week 4, Day 1 of Week 6, Day 1 of Week 8, and Day 1 of Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 on Day 1 of Week 12, Day 1 of Week 13, Day 1 of Week 14 (induction), then every 4 weeks through Week 50. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must give a written and signed informed consent.
- Men or women at least 18 years old at the time of signing the ICF
- Moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form.
- Patients received at least one course of phototherapy or systemic therapy for psoriasis or are candidates for such treatment according to the investigator.
- Body surface area (BSA) affected by psoriasis of 10% or greater, the PASI score of 10 or greater, and the sPGA score of 3 or greater at screening.
Key exclusion criteria (45 listed)
- Baseline erythrodermic, pustular, and guttate psoriasis or any other skin diseases (e.g. eczema) that can affect/complicate assessment of psoriasis treatment
- Use of the following medications:
- Any active systemic infection or recurrent infection at screening/randomization
- HIV, hepatitis B, hepatitis C, or syphilis
- Blood biochemistry abnormalities appearing as:
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 |
|---|---|---|
| BCD-085 Q2WAlso: BCD-085In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54. | Drug | BCD-085 Q2W |
| BCD-085 Q4WAlso: BCD-085In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54. | Drug | BCD-085 Q4W |
| PlaceboIn Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54. | Drug | Placebo |
Primary outcome
• The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment
Time frame: week 12
The Psoriasis Area and Severity Index (PASI) allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). Relative (percentage) change in PASI score from baseline (screening) is calculated as 100 x (baseline value - time point t value) / (baseline value) PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34060012Puig L, Bakulev AL, Kokhan MM, Samtsov AV, Khairutdinov VR, Morozova MA, Zolkin NA, Kuryshev IV, Petrov AN, Artemeva AV, Zinkina-Orikhan AV. Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial. Dermatol Ther (Heidelb). 2021 Aug;11(4):1319-1332. doi: 10.1007/s13555-021-00554-4. Epub 2021 May 31.
- 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.
Roman Ivanov, PhD study chair
Vice-president, R&D, International business development BIOCAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-085 Q2W and BCD-085 Q4W in people with Moderate to Severe Plaque Psoriasis, run by Biocad at 1 site in Russia.
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 45 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 1 Jun 2022. 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 Russia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
• The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (time frame: week 12). 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 NCT03390101, 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 1 Jun 2022.