NCT03835481 is a Phase 2 clinical trial of BI 730357 in Psoriasis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03835481?

NCT03835481 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03835481?

Interventions in NCT03835481: BI 730357, Placebo to match BI 730357.

Is NCT03835481 still recruiting?

NCT03835481 is currently terminated. Last updated 18 November 2022.

Are results published for NCT03835481?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-18 · How we verify

NCT03835481

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is

Terminated Phase 2 Results posted Last updated 18 November 2022

What this trial tests

Phase 2 trial testing BI 730357 in Psoriasis in 165 participants. Terminated before completion.

Timeline

18 March 2019

Primary endpoint
22 June 2021

27 July 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	165
Start date	18 March 2019
Primary completion	22 June 2021
Estimated completion	27 July 2021
Sites	30 locations across Canada, United States, Germany

Drugs / interventions tested

BI 730357 — full drug profile →
Placebo to match BI 730357 — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Eligibility, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · 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.

Group	Value	95% CI
25 mg BI 730357	0
50 mg BI 730357	6
100 mg BI 730357	6
200 mg BI 730357	10
400 mg BI 730357	14
25 mg BI - 100 mg BI	1
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	3
50 mg BI - 100 mg BI - 200 mg BI	8
100 mg BI - 100 mg BI	3
100 mg BI - 100 mg BI - 200 mg BI	6
200 mg BI - 200 mg BI	28

Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 Secondary · At baseline and 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 a

PASI50

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	4
50 mg BI - 100 mg BI - 200 mg BI	12
100 mg BI - 100 mg BI	2
100 mg BI - 100 mg BI - 200 mg BI	8
200 mg BI - 200 mg BI	33
400 mg BI - 400 mg BI	9

PASI75

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	3
50 mg BI - 100 mg BI - 200 mg BI	9
100 mg BI - 100 mg BI	2
100 mg BI - 100 mg BI - 200 mg BI	3
200 mg BI - 200 mg BI	23
400 mg BI - 400 mg BI	6

PASI90

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	4
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	2
200 mg BI - 200 mg BI	10
400 mg BI - 400 mg BI	5

PASI100

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	2
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	0
200 mg BI - 200 mg BI	3
400 mg BI - 400 mg BI	2

Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24 Secondary · 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), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	2
50 mg BI - 100 mg BI - 200 mg BI	5
100 mg BI - 100 mg BI	1
100 mg BI - 100 mg BI - 200 mg BI	3
200 mg BI - 200 mg BI	18
400 mg BI - 400 mg BI	7

Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24 Secondary · 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), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).

Group	Value	95% CI
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	2
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	0
200 mg BI - 200 mg BI	3
400 mg BI - 400 mg BI	2

Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response Secondary · Up to 802 days.

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 achieve

PASI50 Responders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	2
400 mg BI 730357	23
25 mg BI - 100 mg BI	1
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	5
50 mg BI - 100 mg BI - 200 mg BI	13
100 mg BI - 100 mg BI	6
100 mg BI - 100 mg BI - 200 mg BI	9
200 mg BI - 200 mg BI	46
400 mg BI - 400 mg BI	30

PASI50 Loss of Response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	1
400 mg BI 730357	1
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	0
50 mg BI - 100 mg BI - 200 mg BI	1
100 mg BI - 100 mg BI	5
100 mg BI - 100 mg BI - 200 mg BI	3
200 mg BI - 200 mg BI	11
400 mg BI - 400 mg BI	4

PASI75 Responders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	0
400 mg BI 730357	12
25 mg BI - 100 mg BI	1
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	4
50 mg BI - 100 mg BI - 200 mg BI	12
100 mg BI - 100 mg BI	3
100 mg BI - 100 mg BI - 200 mg BI	6
200 mg BI - 200 mg BI	32
400 mg BI - 400 mg BI	21

PASI75 Loss of Response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	0
400 mg BI 730357	1
25 mg BI - 100 mg BI	1
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	2
100 mg BI - 100 mg BI	2
100 mg BI - 100 mg BI - 200 mg BI	1
200 mg BI - 200 mg BI	12
400 mg BI - 400 mg BI	5

PASI90 Responders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	0
400 mg BI 730357	2
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	2
50 mg BI - 100 mg BI - 200 mg BI	5
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	3
200 mg BI - 200 mg BI	21
400 mg BI - 400 mg BI	10

PASI90 Loss of Response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	0
400 mg BI 730357	0
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	0
50 mg BI - 100 mg BI - 200 mg BI	2
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	1
200 mg BI - 200 mg BI	12
400 mg BI - 400 mg BI	2

PASI100 Responders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	0
400 mg BI 730357	1
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	2
50 mg BI - 100 mg BI - 200 mg BI	4
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	1
200 mg BI - 200 mg BI	12
400 mg BI - 400 mg BI	4

PASI100 Loss of Response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	0
400 mg BI 730357	0
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	3
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg BI - 200 mg BI	0
200 mg BI - 200 mg BI	7
400 mg BI - 400 mg BI	1

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 Secondary · Up to 802 days.

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 a

Resonders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	0
400 mg BI 730357	13
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	3
50 mg BI - 100 mg BI - 200 mg BI	9
100 mg BI - 100 mg BI	3
100 mg BI - 100 mg BI - 200 mg BI	6
200 mg BI - 200 mg BI	32
400 mg BI - 400 mg BI	17

Loss of response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	0
400 mg BI 730357	2
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg BI	4
100 mg BI - 100 mg BI	3
100 mg BI - 100 mg BI - 200 mg BI	2
200 mg BI - 200 mg BI	18
400 mg BI - 400 mg BI	3

Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response Secondary · Up to 802 days.

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 respo

Resonders

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	1
200 mg BI 730357	0
400 mg BI 730357	1
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	1
50 mg BI - 100 mg BI	2
50 mg BI - 100 mg BI - 200 mg	4
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg - 200 mg BI	1
200 mg BI - 200 mg BI	12
400 mg BI - 400 mg BI	4

Loss of response

Group	Value	95% CI
50 mg BI 730357	0
100 mg BI 730357	0
200 mg BI 730357	0
400 mg BI 730357	0
25 mg BI - 100 mg BI	0
25 mg BI - 100 mg BI - 200 mg BI	0
50 mg BI - 100 mg BI	1
50 mg BI - 100 mg BI - 200 mg	3
100 mg BI - 100 mg BI	0
100 mg BI - 100 mg - 200 mg BI	0
200 mg BI - 200 mg BI	7
400 mg BI - 400 mg BI	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

25 mg BI 730357 (Actual Dose)

Serious: 0/2 (0%)

Deaths: 0/2

50 mg BI 730357 (Actual Dose)

Serious: 1/20 (5%)

Deaths: 0/20

100 mg BI 730357 BI (Actual Dose)

Serious: 3/36 (8%)

Deaths: 0/36

200 mg BI 730357 (Actual Dose)

Serious: 3/72 (4%)

Deaths: 0/72

400 mg BI 730357 (Actual Dose)

Serious: 0/78 (0%)

Deaths: 0/78

Serious adverse events (8 terms)

Reaction	System	25 mg BI 730357 (Actual Do…	50 mg BI 730357 (Actual Do…	100 mg BI 730357 BI (Actua…	200 mg BI 730357 (Actual D…	400 mg BI 730357 (Actual D…
Pericarditis	Cardiac disorders	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	25 mg BI 730357 (Actual Do…	50 mg BI 730357 (Actual Do…	100 mg BI 730357 BI (Actua…	200 mg BI 730357 (Actual D…	400 mg BI 730357 (Actual D…
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—

Most-reported serious reactions: Pericarditis, Erysipelas, Pyelonephritis, Urosepsis, Tendon rupture, Basal cell carcinoma, Squamous cell carcinoma of skin, Nephrolithiasis.

Data from ClinicalTrials.gov NCT03835481 adverse events section.

Sponsor's own description

To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Key Signaling Pathways in Psoriasis: Recent Insights from Antipsoriatic Therapeutics.
Ben Abdallah H, Johansen C, Johansen C, Iversen L. · · 2021 · cited 48× · PMID 34235053 · DOI 10.2147/ptt.s294173
New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239
A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9
Discovery of a Series of Pyrazinone RORγ Antagonists and Identification of the Clinical Candidate BI 730357.
Harcken C, Csengery J, Turner M, Wu L, et al · · 2021 · cited 15× · PMID 33488976 · DOI 10.1021/acsmedchemlett.0c00575
Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357.
Ooi QX, Kristoffersson A, Korell J, Flack M, et al · · 2023 · cited 7× · PMID 36919398 · DOI 10.1002/psp4.12948
Phase II Randomized Trial of BI 730357, an Oral RORγt Inhibitor, for Moderate-to-Severe Plaque Psoriasis.
Gooderham MJ, Mrowietz U, Kadus W, Drda K, et al · · 2025 · cited 4× · PMID 39848568 · DOI 10.1016/j.jid.2024.12.025
Current and Emerging Therapies Targeting the IL-23/IL-17 Axis in Psoriasis.
Han SJ, Jung GY, Lee GC, Ki DH, et al · · 2026 · PMID 42059024 · DOI 10.4062/biomolther.2026.019

Verify or expand the search:

Other trials of BI 730357

Trials testing the same drug.

NCT04680676 — A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic A · Phase 2 · withdrawn
NCT04679948 — A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazol · Phase 1 · completed
NCT04590937 — A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and · Phase 1 · completed
NCT04147260 — Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin · Phase 1 · completed
NCT03804671 — A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet · Phase 1 · completed

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03835481 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 18 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03835481.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing