PsoriasisPhase 2NCT03835481
A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
A Phase 2 study testing BI 730357 in people with Psoriasis, run by Boehringer Ingelheim at 30 sites in 3 countries.
Trial summary
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- BI 730357
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 18 Mar 2019to 27 Jul 2021
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
- Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and
- for patients entering from Part 1 of trial 1407-0030
- --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit
- for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Who cannot join
- Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
- Previous enrolment in this trial.
- Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
- Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- Any plan to receive a live vaccination during the conduct of the trial.
- Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
Show all 14Show fewer
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
- Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis and tuberculosis.
- Evidence of a disease (including known or suspected IBD, cardiovascular disease), or medical finding that in the opinion of the Investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
- Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past.
- Unwillingness to adhere to the rules of UV-light protection
- Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States15 sites
Hamilton Research
Alpharetta, Georgia, 30022
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Menter Dermatology Research Institute
Dallas, Texas, 75246
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Center for Clinical Studies
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Research Associates
Los Angeles, California, 90045
Icahn School of Medicine at Mount Sinai
New York, New York, 10003
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Health Concepts
Rapid City, South Dakota, 57702
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Southern California Dermatology Inc.
Santa Ana, California, 92701
Center for Clinical Studies
Webster, Texas, 77598
Canada10 sites
Dr. Irina Turchin PC Inc.
Fredericton, New Brunswick, E3B 1G9
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
DermEdge Research Inc.
Mississauga, Ontario, L5H 1G9
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Dr Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, N8W 1E6
Germany5 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
TFS Trial Form Support GmbH
Hamburg, 20537
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Universitätsklinikum Münster
Münster, 48149
About this study
Official title: Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- BI 730357, Placebo to match BI 730357
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 730357Drug
Film-coated tablet
Placebo to match BI 730357Drug
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| 25 mg BI 730357 | Experimental | 25 mg BI 730357 + placebo under fasted conditions. Receives: Drug: BI 730357; Drug: Placebo to match BI 730357 |
| 50 mg BI 730357 | Experimental | 50 mg BI 730357 + placebo under fasted conditions. Receives: Drug: BI 730357; Drug: Placebo to match BI 730357 |
| 100 mg BI 730357 | Experimental | 100 mg BI 730357 + placebo under fasted conditions. Receives: Drug: BI 730357; Drug: Placebo to match BI 730357 |
| 200 mg BI 730357 | Experimental | 200 mg BI 730357 + placebo under fasted conditions Receives: Drug: BI 730357; Drug: Placebo to match BI 730357 |
| 400 mg BI 730357 | Experimental | 400 mg BI 730357 + placebo under fasted conditions. Receives: Drug: BI 730357 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2.
Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg).
Period 2: Only patients who participated in period 2 are reported by dose sequence group.
For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
Measured: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Secondary outcomes (6)
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score.
The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100.
The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) *100, at all visits with PASI collected.
Measured: At baseline and at week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.
0= clear (no signs of psoriasis),
- almost clear;
- mild;
- moderate; 4 = severe (e.g. deep dark red coloration).
Measured: At week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.
0= clear (No signs of psoriasis),
- almost clear;
- mild;
- moderate; 4 = severe (e.g. deep dark red coloration).
Measured: At week 24.
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported.
PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome.
A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date.
A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Measured: Up to 802 days.
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported.
The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).
A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Measured: Up to 802 days.
Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response
The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported.
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).
A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date.
A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
Measured: Up to 802 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start18 Mar 2019
- Primary completion22 Jun 2021
- Study completion27 Jul 2021
Why it stopped: Due to company decision.
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 (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835481
- Sponsor's protocol ID
- 1407-0005
- Other IDs
- 2018-003487-31, 2018
- Status last verified
- Oct 2022
- First submitted
- 7 Feb 2019
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Publications
Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
PubMed 39848568Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
PubMed 36919398
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03835481
- Acronym / sponsor ID
- 1407-0005
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to company decision.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 25 mg BI 730357 | Experimental | Drug: BI 730357, Drug: Placebo to match BI 73035725 mg BI 730357 + placebo under fasted conditions. |
| 50 mg BI 730357 | Experimental | Drug: BI 730357, Drug: Placebo to match BI 73035750 mg BI 730357 + placebo under fasted conditions. |
| 100 mg BI 730357 | Experimental | Drug: BI 730357, Drug: Placebo to match BI 730357100 mg BI 730357 + placebo under fasted conditions. |
| 200 mg BI 730357 | Experimental | Drug: BI 730357, Drug: Placebo to match BI 730357200 mg BI 730357 + placebo under fasted conditions |
| 400 mg BI 730357 | Experimental | Drug: BI 730357400 mg BI 730357 + placebo under fasted conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
- Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and
- --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Key exclusion criteria (14 listed)
- Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
- Previous enrolment in this trial.
- Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
- Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- Any plan to receive a live vaccination during the conduct of the trial.
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 |
|---|---|---|
| BI 730357Film-coated tablet | Drug | 100 mg BI 730357, 200 mg BI 730357, 25 mg BI 730357, 400 mg BI 730357, 50 mg BI 730357 |
| Placebo to match BI 730357Film-coated tablet | Drug | 100 mg BI 730357, 200 mg BI 730357, 25 mg BI 730357, 50 mg BI 730357 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
6 secondary outcomes
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
Time frame: At baseline and at week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
Time frame: At week 24.
Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
Time frame: At week 24.
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
Time frame: Up to 802 days.
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
Time frame: Up to 802 days.
Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response
Time frame: Up to 802 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39848568Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
- Derived from this study: PubMed 36919398Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 730357 in people with Psoriasis, run by Boehringer Ingelheim at 30 sites in 3 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Nov 2022). 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.). 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 NCT03835481, which also lists 2 linked publications.
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 18 Nov 2022.