PsoriasisPhase 1NCT03469336

Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

A Phase 1 study testing PF-06763809, Calcipotriene/calcipotriol and Betamethasone in people with Psoriasis, run by Pfizer at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: PF-06763809, Calcipotriene/calcipotriol and Betamethasone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesGermany
Study dates: 24 Apr 2018to 20 Mar 2019
Phase: Phase 1
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

Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas
Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

Who cannot join

History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
Treatment with any biologics within 3 months prior to Day 1 of the study and during the study

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Rothaar Studien GmbH
Berlin, 10783
bioskin GmbH
Hamburg, 20095

Other trials in Germany

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS

The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.

Conditions: Psoriasis
Being tested: PF-06763809, Vehicle, Calcipotriene/calcipotriol, Betamethasone
Keywords: Psoriasis, Topical
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06763809Drug
Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
VehicleOther
Vehicle matching PF-06763809.
Calcipotriene/calcipotriolDrug
Calcipotriene/calcipotriol 50 ug/mL solution
BetamethasoneDrug
Betamethasone 1 mg/g solution

Study groups in NCT03469336
Study group	Role	What they receive
All subjects	Other	All subjects will receive all six interventions/treatments applied to six different treatment fields. Receives: Drug: PF-06763809; Other: Vehicle; Drug: Calcipotriene/calcipotriol; Drug: Betamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Psoriatic Skin Infiltrate Thickness
Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Measured: Baseline, Days 7, 13 and 19
Number of Participants With Treatment-emergent Adverse Events (AEs)
Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.
Measured: Day 1 to Day 49
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.
Measured: Day 1 to Day 49
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value>=300 milliseconds [msec], %Change [Chg]>=25/50%); 2) QRS interval (Value>=140 msec, >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec. The corrected QT interval by Fredericia=QTcF Interval.
Measured: Day 1 to Day 49
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.
Measured: Day 1 to Day 49

Secondary outcomes (3)

Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Measured: Day 1 to Day 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Measured: Baseline, Days 7, 13 and 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Measured: Baseline, Days 7, 13 and 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201820 Mar 2019

First posted19 Mar 2018
Study start24 Apr 2018
Primary completion20 Mar 2019
Study completion20 Mar 2019

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 PsoriasisStudies of the same condition, open and under way.
More trials run by PfizerThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03469336
Sponsor's protocol ID: C3561001
Other IDs: 2017-002684-18, 2017
Status last verified: Jun 2020
First submitted: 13 Mar 2018
Last updated: 25 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Berstein G, Zhang Y, Berger Z, Kieras E, Li G, Samuel A, Yeoh T, Dowty H, Beaumont K, Wigger-Alberti W, von Mackensen Y, Kroencke U, Hamscho R, Garcet S, Krueger JG, Banfield C, Oemar B. A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis. Clin Exp Dermatol. 2021 Jan;46(1):122-129. doi: 10.1111/ced.14412. Epub 2020 Sep 14.
PubMed 32767679

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
ClinicalTrials.gov ID: NCT03469336
Acronym / sponsor ID: C3561001
Conditions: Psoriasis
Keywords: Psoriasis, Topical
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 Apr 2018 (actual)
Primary completion: 20 Mar 2019 (actual)
Study completion: 20 Mar 2019 (actual)
First posted: 19 Mar 2018 (actual)
Results: Posted 25 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects	Other	Drug: PF-06763809, Other: Vehicle, Drug: Calcipotriene/calcipotriol, Drug: BetamethasoneAll subjects will receive all six interventions/treatments applied to six different treatment fields.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas
Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

Key exclusion criteria (3 listed)

History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
Treatment with any biologics within 3 months prior to Day 1 of the study and during the study

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
PF-06763809Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%	Drug	All subjects
VehicleVehicle matching PF-06763809.	Other	All subjects
Calcipotriene/calcipotriolCalcipotriene/calcipotriol 50 ug/mL solution	Drug	All subjects
BetamethasoneBetamethasone 1 mg/g solution	Drug	All subjects

Primary outcome

Change From Baseline in Psoriatic Skin Infiltrate Thickness
Time frame: Baseline, Days 7, 13 and 19
Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: Day 1 to Day 49
Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Day 1 to Day 49
Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
Time frame: Day 1 to Day 49
Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value>=300 milliseconds [msec], %Change [Chg]>=25/50%); 2) QRS interval (Value>=140 msec, >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec. The corrected QT interval by Fredericia=QTcF Interval.
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
Time frame: Day 1 to Day 49
Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.

3 secondary outcomes

Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
Time frame: Day 1 to Day 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
Time frame: Baseline, Days 7, 13 and 19
Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
Time frame: Baseline, Days 7, 13 and 19

Results and safety

Results posted to the registry on 25 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-06763809+Vehicle+Calcipotriene+Betamethasone	18	17

Primary outcome: Change From Baseline in Psoriatic Skin Infiltrate Thickness

Time frame: Baseline, Days 7, 13 and 19. Geometric mean (Standard Error). Unit: micrometer (μm)

Measure	A: PF-06763809 2.3% Solution n = 18	B: PF-06763809 0.8% Solution n = 18	C: PF-06763809 0.23% Solution n = 18	D: PF-06763809 Vehicle n = 18
Day 7	0.89 (0.073)	0.92 (0.073)	0.97 (0.073)	0.93 (0.073)
Day 13	0.74 (0.458)	0.76 (0.458)	0.87 (0.458)	0.80 (0.458)
Day 19	0.71 (0.526)	0.70 (0.526)	0.80 (0.526)	0.70 (0.526)

A: PF-06763809 2.3% Solution vs D: PF-06763809 Vehicle: Mean Ratio (Test/Reference): 1.0109 (95% CI 0.2364 to 4.3226), p = 0.9883, Mixed Models Analysis
B: PF-06763809 0.8% Solution vs D: PF-06763809 Vehicle: Mean Ratio (Test/Reference): 0.9979 (95% CI 0.2334 to 4.2671), p = 0.9977, Mixed Models Analysis
C: PF-06763809 0.23% Solution vs D: PF-06763809 Vehicle: Mean Ratio (Test/Reference): 1.1382 (95% CI 0.2662 to 4.8670), p = 0.8600, Mixed Models Analysis

Population analysed: Analysis population included all participants who had at least one application of the investigational products and had at least one post-baseline assessment of the primary efficacy variable, were included in the Full Analysis Set (FAS).

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (AEs)

Time frame: Day 1 to Day 49. Count of participants. Unit: Participants

Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone n = 18
Value	6

Population analysed: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value.

Primary outcome: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Time frame: Day 1 to Day 49. Count of participants. Unit: Participants

Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone n = 18
Hemoglobin (HGB) (g/dL) <0.8xLLN	0
Hematocrit (%) <0.8xLLN	0
Erythrocytes (10^6/mm^3) <0.8xLLN	0
Ery. Mean Corpuscular Volume (μm^3) <0.9xLLN	0
Ery. Mean Corpuscular Volume (μm^3) >1.1xULN	1
Ery. Mean Corpuscular HGB (pg/cell) <0.9xLLN	0
Ery. Mean Corpuscular HGB (pg/cell) >1.1xULN	0
Ery. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLN	1

Population analysed: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value.

Primary outcome: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

Time frame: Day 1 to Day 49. Count of participants. Unit: Participants

Measure	PF-06763809+Vehicle+Calcipotriene+Betamethasone n = 18
Value>=300 msec (PR Interval)	0
%Change (Chg)>=25/50% (PR Interval)	0
Value>=140 msec (QRS Interval)	0
%Chg>=50% (QRS Interval)	0
Value>=500 msec (QT Interval)	0
450<=Value<480 msec (QTc Interval)	2
480<=Value<500 msec (QTc Interval)	0
Value>=500 msec (QTc Interval)	0

Population analysed: Analysis population included all participants who received at least one application of the investigational products and had at least one post-baseline efficacy assessment value. All scheduled ECGs were performed after the participant had rested quietly for 10 minutes in a supine position.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 49. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06763809+Vehicle+Calcipotriene+Betamethasone	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32767679Berstein G, Zhang Y, Berger Z, Kieras E, Li G, Samuel A, Yeoh T, Dowty H, Beaumont K, Wigger-Alberti W, von Mackensen Y, Kroencke U, Hamscho R, Garcet S, Krueger JG, Banfield C, Oemar B. A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis. Clin Exp Dermatol. 2021 Jan;46(1):122-129. doi: 10.1111/ced.14412. Epub 2020 Sep 14.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

2 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 PF-06763809, Calcipotriene/calcipotriol and Betamethasone in people with Psoriasis, run by Pfizer at 2 sites in Germany.

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 2 inclusion and 3 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 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?

Yes. Results are posted in the registry (first posted 25 Jun 2020). 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?

Change From Baseline in Psoriatic Skin Infiltrate Thickness (time frame: Baseline, Days 7, 13 and 19). The study lists 5 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 NCT03469336, 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 25 Jun 2020.