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Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis

Summary
EudraCT number	2022-002633-34
Trial protocol	CZ PL
Global end of trial date	25 Jul 2023

Results information
Results version number	v1(current)
This version publication date	16 Nov 2024
First version publication date	16 Nov 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

ESK-001-006

ISRCTN number

US NCT number

NCT05600036

WHO universal trial number (UTN)

Other trial identifiers

IND Number : 159386

Sponsor organisation name

Alumis Inc.

Sponsor organisation address

280 East Grand Avenue, South San Francisco, United States, 94080

Public contact

Clinical Trial Information Desk , Alumis Inc., 1 (650) 231-6625, info@alumis.com

Scientific contact

Clinical Trial Information Desk , Alumis Inc., 1 (650) 231-6625, info@alumis.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Jun 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Jun 2023

Global end of trial reached?

Yes

Global end of trial date

25 Jul 2023

Was the trial ended prematurely?

Main objective of the trial

To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo after 12 weeks of treatment. An independent Safety Monitoring Committee was utilized for monitoring the safety data in this study.

Protection of trial subjects

This study was conducted in compliance with the Institutional Review Board (IRB) regulations stated in Title 21 of the United States Code of Federal Regulations (CFR), Part 56, Good Clinical Practice (GCP) regulations and guidelines, and all applicable local regulations. A waiver of the IRB requirements under 21 CFR Part 56 was granted for all foreign investigational studies conducted under IND 159386. The clinical study protocol, the Investigator’s Brochure, a sample informed consent form (ICF), and other study-related documents were reviewed and approved by the local or central IRBs of all study sites. This study was conducted with the highest respect for the individual patients and in accordance with the Protocol, the ethical principles that have their origin in the Declaration of Helsinki, the informed consent regulations stated in Title 21 CFR, Part 50, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP (E6) §4.8, and all applicable local regulations. This study was conducted in compliance with the informed consent regulations stated in Title 21 CFR, Part 50. The Investigator explained the study and its objectives as well as potential risks and benefits to patients using the IRB-approved ICF. Each patient or their legal guardian/legally authorized representative signed and dated the ICF before any study-specific procedures were performed.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Sep 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 157

Country: Number of subjects enrolled

Canada: 44

Country: Number of subjects enrolled

Czechia: 27

Worldwide total number of subjects

228

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

206

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

In total, 312 patients were screened for study participation. Of the total 312 patients screened, 84 (26.9%) failed Screening primarily due to eligibility criteria not being met, and 2 patients were rescreened. Of the 228 patients randomized, a total of 227 patients (99.6%) were dosed and 209 patients (91.7%) completed treatment.

Screening details

Screening was done per protocol inclusion/exclusion criteria.

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

For this trial, study patients, Investigators, study center personnel, the Sponsor, or representatives on the clinical study team were all blinded to the treatment assignments. ESK-001 tablets and placebo-to-match ESK-001 tablets were matched for shape, size, and color.

Are arms mutually exclusive

10 mg QD

Arm description

ESK-001 10 mg once a day.

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

10 mg taken orally once a day.

20 mg QD

Arm description

ESK-001 20 mg once a day.

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

20 mg taken orally once a day.

40 mg QD

Arm description

ESK-001 40 mg once a day.

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

40 mg taken orally once a day.

20 mg BID

Arm description

ESK-001 20 mg twice a day.

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

20 mg taken orally twice a day.

40 mg BID

Arm description

ESK-001 40 mg twice a day.

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

40 mg taken orally twice a day.

Placebo

Arm description

Placebo tablets for oral administration.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Placebo tablets for oral administration.

All active

Arm description

All active including QD (10, 20 and 40 mg) plus BID (20 and 40 mg)

Arm type

Experimental

Investigational medicinal product name

ESK-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

10 mg QD or; 20 mg QD or; 40 mg QD or; 20 mg BID or; 40 mg BID

Number of subjects in period 1	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	All active
Started	36	36	39	40	39	38	190
Completed	36	30	33	37	35	33	171
Not completed	0	6	6	3	4	5	19
Consent withdrawn by subject	-	1	2	-	3	5	6
Adverse event, non-fatal	-	2	1	-	1	-	4
Other reasons	-	1	-	2	-	-	3
Lost to follow-up	-	2	1	1	-	-	4
Protocol deviation	-	-	2	-	-	-	2

Baseline characteristics

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Reporting group title

10 mg QD

Reporting group description

ESK-001 10 mg once a day.

Reporting group title

20 mg QD

Reporting group description

ESK-001 20 mg once a day.

Reporting group title

40 mg QD

Reporting group description

ESK-001 40 mg once a day.

Reporting group title

20 mg BID

Reporting group description

ESK-001 20 mg twice a day.

Reporting group title

40 mg BID

Reporting group description

ESK-001 40 mg twice a day.

Reporting group title

Placebo

Reporting group description

Placebo tablets for oral administration.

Reporting group title

All active

Reporting group description

All active including QD (10, 20 and 40 mg) plus BID (20 and 40 mg)

Reporting group values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	All active	Total
Number of subjects	36	36	39	40	39	38	190	228
Age categorical
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: Subjects
In utero	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0
Adults (18-64 years)	33	33	37	35	33	35	171	206
From 65-84 years	3	3	2	5	6	3	19	22
85 years and over	0	0	0	0	0	0	0	0
Age continuous
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: years
median (inter-quartile range (Q1-Q3))	49.0 (40.0 to 61.0)	42.0 (37.0 to 49.0)	49.0 (44.0 to 56.0)	49.5 (38.5 to 58.0)	45.0 (36.0 to 61.0)	50.5 (42.0 to 59.0)	47.0 (38.0 to 57.0)	-
Gender categorical
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: Subjects
Female	12	12	13	17	13	7	67	74
Male	24	24	26	23	26	31	123	154

Subject analysis set title

Intent-To-Treat (ITT)

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized patients, regardless of whether they received study drug, with analyses conducted according to the assigned treatment.

Subject analysis set title

Modified Intent-To-Treat

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized patients who received at least 1 dose of study drug, with analyses conducted according to the assigned treatment. This is the analysis population used for the primary efficacy analysis at Week 12.

Subject analysis set title

Safety Analysis set

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized patients who received at least 1 dose of study drug with analyses conducted by actual treatment received.

Subject analysis sets values	Intent-To-Treat (ITT)	Modified Intent-To-Treat	Safety Analysis set
Number of subjects	228	227	227
Age categorical
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	206	205	205
From 65-84 years	22	22	22
85 years and over	0	0	0
Age continuous
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: years
median (inter-quartile range (Q1-Q3))	48 (39 to 58)
Gender categorical
The reporting group includes a total of 228 Intent-to-treat participants. 38 participants received Placebo whereas 190 participants were assigned to active treatment at the dose levels described.
Units: Subjects
Female	74
Male	154

End points

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Reporting group title

10 mg QD

Reporting group description

ESK-001 10 mg once a day.

Reporting group title

20 mg QD

Reporting group description

ESK-001 20 mg once a day.

Reporting group title

40 mg QD

Reporting group description

ESK-001 40 mg once a day.

Reporting group title

20 mg BID

Reporting group description

ESK-001 20 mg twice a day.

Reporting group title

40 mg BID

Reporting group description

ESK-001 40 mg twice a day.

Reporting group title

Placebo

Reporting group description

Placebo tablets for oral administration.

Reporting group title

All active

Reporting group description

All active including QD (10, 20 and 40 mg) plus BID (20 and 40 mg)

Subject analysis set title

Intent-To-Treat (ITT)

Subject analysis set type

Intention-to-treat

Subject analysis set description

All randomized patients, regardless of whether they received study drug, with analyses conducted according to the assigned treatment.

Subject analysis set title

Modified Intent-To-Treat

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subject analysis set title

Safety Analysis set

Subject analysis set type

Safety analysis

Subject analysis set description

All randomized patients who received at least 1 dose of study drug with analyses conducted by actual treatment received.

Primary: Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

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End point title

Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

End point description

Efficacy endpoint analysis was done on the Modified Intent-to-Treat subset. Disease activity was assessed using Psoriasis Area and Severity Index (PASI), a grading system that derives a score for the severity of psoriatic lesions. The primary endpoint in this study was the proportion of patients achieving ≥75% reduction in PASI (PASI-75) at Week 12. Data is presented here as the count of responders meeting the primary efficacy endpoint. The p-value is for comparison of the proportion of responders (Count of Responders/Number of participants) in each active group vs placebo using the CMH test adjusted for stratification factors.

End point type

Primary

End point timeframe

At week 12

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	All active
Number of subjects analysed	36	36	39	39	39	38	189
Units: Participants	7	12	22	22	25	0	88

ESK-001 10mg QD vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

10 mg QD v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0025

Method

Cochran-Mantel-Haenszel

Confidence interval

ESK-001 20mg QD vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

20 mg QD v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

ESK-001 40mg QD vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

Placebo v 40 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

ESK-001 20mg BID vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

20 mg BID v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

ESK-001 40mg BID vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

40 mg BID v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

All active vs Placebo

Statistical analysis description

The p-value was comparing the proportion of responders in each active group vs placebo using the CMH test adjusted for stratification factors.

Comparison groups

All active v Placebo

Number of subjects included in analysis

227

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Incidence of treatment-emergent adverse events (TEAEs)

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End point title

Incidence of treatment-emergent adverse events (TEAEs) ^[1]

End point description

TEAEs were defined as AEs occurring at any time point from first dose through the end of study (Week 16) for patients who complete the full Treatment Period of 12 weeks. If a patient discontinued study drug early, then the treatment-emergent period was first dose through 4 weeks after last dose.

End point type

Secondary

End point timeframe

Week 16 (4 weeks after last dose at week 12) or 4 weeks after early discontinuation.

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	Safety Analysis set
Number of subjects analysed	36	36	39	39	39	38	227
Units: Participants	19	14	19	18	25	15	110

No statistical analyses for this end point

Secondary: Incidence of serious adverse events (SAEs)

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End point title

Incidence of serious adverse events (SAEs) ^[2]

End point description

The data presented here are Treatment-Emergent Adverse Events considered as Serious Adverse Events (any adverse event resulting in death, life-threatening emergency, prolonged hospitalization, or persistent and significant disability, regardless of expectedness and relatedness to the study drug or study procedures). The safety analysis dataset was used for this endpoint.

End point type

Secondary

End point timeframe

Week 16 (4 weeks after last dose at week 12) or 4 weeks after early discontinuation.

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	Safety Analysis set
Number of subjects analysed	36	36	39	39	39	28	227
Units: Participants	1	0	1	3	0	0	5

No statistical analyses for this end point

Secondary: Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo

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End point title

Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo ^[3]

End point description

The number of patients that achieved an sPGA response (defined as a score of 0 [“cleared”] or 1 [“minimal”], sPGA-0/1) at week 12.

End point type

Secondary

End point timeframe

Week 12

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo
Number of subjects analysed	36	35	35	37	36	34
Units: Participants	6	14	21	19	23	3

No statistical analyses for this end point

Secondary: Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo

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End point title

Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo ^[4]

End point description

This secondary endpoint measures the proportion of patients achieving ≥90% reduction in PASI (PASI-90) at Week 12. Data is presented here as the count of responders meeting this secondary endpoint.

End point type

Secondary

End point timeframe

Week 12

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	Modified Intent-To-Treat
Number of subjects analysed	36	36	39	39	39	38	227
Units: Participants	0	4	10	10	15	0	39

No statistical analyses for this end point

Secondary: Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo

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End point title

Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo ^[5]

End point description

This secondary endpoint measures the proportion of patients achieving 100% reduction in PASI (PASI-100) at Week 12. Data is presented here as the count of responders meeting this secondary endpoint.

End point type

Secondary

End point timeframe

Week 12

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo	Modified Intent-To-Treat
Number of subjects analysed	36	36	39	39	39	38	227
Units: Participants	0	0	3	4	6	0	13

No statistical analyses for this end point

Secondary: Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo.

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End point title

Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo. ^[6]

End point description

This secondary outcome reports the change in percent Body Surface Area (BSA) from baseline after 12 weeks of treatment. BSA is measure used to assess the severity of Psoriasis. Involvement of <3% BSA is considered mild, 3%-10% BSA is considered moderate and >10% of BSA is considered severe psoriasis.

End point type

Secondary

End point timeframe

Week 12

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo
Number of subjects analysed	36	35	35	37	36	34
Units: Mean change from baseline
arithmetic mean (standard deviation)	-6.86 ( 7.791 )	-7.49 ( 8.082 )	-14.63 ( 14.244 )	-14.05 ( 12.895 )	-14.06 ( 12.102 )	-3.24 ( 6.849 )

No statistical analyses for this end point

Secondary: Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo

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End point title

Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo ^[7]

End point description

This secondary outcome reports the mean change in Dermatology Life Quality Index (DLQI) score after 12 weeks of treatment.

End point type

Secondary

End point timeframe

Week 12

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical analyses for all the arms is being reported only for the primary endpoint.

End point values	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo
Number of subjects analysed	35	34	33	37	33	34
Units: Mean change in DLQI score from baseline
arithmetic mean (standard deviation)	-3.91 ( 5.878 )	-4.97 ( 6.255 )	-7.21 ( 7.066 )	-7.24 ( 6.878 )	-8.39 ( 6.538 )	-0.68 ( 6.049 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Event data was collected from Screening through end of study (Week 16)

Adverse event reporting additional description

The data presented here are Treatment-Emergent Serious Adverse Events (SAE's).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

10 mg QD

Reporting group description

ESK-001 10 mg once a day.

Reporting group title

20 mg QD

Reporting group description

ESK-001 20 mg once a day.

Reporting group title

40 mg QD

Reporting group description

ESK-001 40 mg once a day.

Reporting group title

20 mg BID

Reporting group description

ESK-001 20 mg twice a day.

Reporting group title

40 mg BID

Reporting group description

ESK-001 40 mg twice a day.

Reporting group title

Placebo

Reporting group description

Placebo tablets for oral administration.

Serious adverse events	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 39 (2.56%)	3 / 39 (7.69%)	0 / 39 (0.00%)	0 / 38 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Injury, poisoning and procedural complications
Lower Limb Fracture
subjects affected / exposed	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 39 (0.00%)	0 / 39 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tibia Fracture
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Coronary artery occlusion
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis contact
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	10 mg QD	20 mg QD	40 mg QD	20 mg BID	40 mg BID	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	8 / 36 (22.22%)	4 / 36 (11.11%)	11 / 39 (28.21%)	18 / 39 (46.15%)	18 / 39 (46.15%)	9 / 38 (23.68%)
Nervous system disorders
Headache
subjects affected / exposed	0 / 36 (0.00%)	2 / 36 (5.56%)	4 / 39 (10.26%)	3 / 39 (7.69%)	3 / 39 (7.69%)	2 / 38 (5.26%)
occurrences all number	0	2	4	3	3	2
Dizziness
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 39 (2.56%)	2 / 39 (5.13%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences all number	0	0	1	2	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	2 / 39 (5.13%)	0 / 38 (0.00%)
occurrences all number	0	0	0	1	2	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 39 (2.56%)	2 / 39 (5.13%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences all number	1	0	1	2	0	0
Dyspepsia
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	2 / 39 (5.13%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences all number	0	0	0	2	0	0
Nausea
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	2 / 39 (5.13%)	0 / 39 (0.00%)	1 / 38 (2.63%)
occurrences all number	0	0	0	2	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	2 / 39 (5.13%)	2 / 39 (5.13%)	0 / 38 (0.00%)
occurrences all number	0	0	0	2	2	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	2 / 39 (5.13%)	0 / 39 (0.00%)	2 / 39 (5.13%)	0 / 38 (0.00%)
occurrences all number	0	0	2	0	2	0
Dermatitis acneiform
subjects affected / exposed	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 39 (0.00%)	0 / 39 (0.00%)	2 / 39 (5.13%)	0 / 38 (0.00%)
occurrences all number	1	0	0	0	2	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	2 / 36 (5.56%)	2 / 36 (5.56%)	2 / 39 (5.13%)	1 / 39 (2.56%)	3 / 39 (7.69%)	0 / 38 (0.00%)
occurrences all number	2	2	2	1	3	0
Nasopharyngitis
subjects affected / exposed	2 / 36 (5.56%)	0 / 36 (0.00%)	1 / 39 (2.56%)	1 / 39 (2.56%)	3 / 39 (7.69%)	3 / 38 (7.89%)
occurrences all number	2	0	1	1	3	3
COVID-19
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	1 / 39 (2.56%)	3 / 38 (7.89%)
occurrences all number	0	0	0	1	1	3
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	2 / 36 (5.56%)	0 / 36 (0.00%)	0 / 39 (0.00%)	1 / 39 (2.56%)	0 / 39 (0.00%)	0 / 38 (0.00%)
occurrences all number	2	0	0	1	0	0

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

Primary: Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

Secondary: Incidence of treatment-emergent adverse events (TEAEs)

Secondary: Incidence of treatment-emergent adverse events (TEAEs)

Secondary: Incidence of serious adverse events (SAEs)

Secondary: Incidence of serious adverse events (SAEs)

Secondary: Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo.

Secondary: Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo.

Secondary: Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo

Secondary: Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

Primary: Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score at 12 weeks.

Secondary: Incidence of treatment-emergent adverse events (TEAEs)

Secondary: Incidence of treatment-emergent adverse events (TEAEs)

Secondary: Incidence of serious adverse events (SAEs)

Secondary: Incidence of serious adverse events (SAEs)

Secondary: Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving an sPGA score of “0” (“cleared”) or “1” (“minimal”) after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-90 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Proportion of patients achieving PASI-100 after 12 weeks of ESK-001 treatment compared with placebo

Secondary: Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo.

Secondary: Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo.

Secondary: Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo

Secondary: Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis