NCT03635099 is a Phase 2 clinical trial of BI 25 mg (fasted) in Psoriasis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03635099?

NCT03635099 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03635099?

Interventions in NCT03635099: Placebo (fasted), BI 25 mg (fasted), BI 50 mg (fasted), BI 100 mg (fasted), BI 200 mg (fasted), Placebo (fed), BI 400 mg once daily (fed), BI 200 mg twice daily, 400 mg total (fed).

Is NCT03635099 still recruiting?

NCT03635099 is currently completed. Last updated 3 August 2022.

Are results published for NCT03635099?

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

Last reviewed 2022-08-03 · How we verify

NCT03635099

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

This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is

Completed Phase 2 Results posted Last updated 3 August 2022

What this trial tests

Phase 2 trial testing Placebo (fasted) in Psoriasis in 274 participants. Completed in 26 May 2021.

Timeline

17 September 2018

Primary endpoint
6 May 2021

26 May 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	274
Start date	17 September 2018
Primary completion	6 May 2021
Estimated completion	26 May 2021
Sites	34 locations across Canada, United States, Germany

Drugs / interventions tested

Placebo (fasted) — full drug profile →
BI 25 mg (fasted) — full drug profile →
BI 50 mg (fasted)
BI 100 mg (fasted) — full drug profile →
BI 200 mg (fasted)
Placebo (fed)
BI 400 mg once daily (fed) — full drug profile →
BI 200 mg twice daily, 400 mg total (fed) — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 75, 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 Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12 Primary · Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. 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. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reductio

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	2
Part I - BI 50 mg (Fasted)	3
Part I - BI 100 mg (Fasted)	4
Part I - BI 200 mg (Fasted)	12
Part II - Placebo (Fed)	0
Part II - BI 400 mg Once Daily (Fed)	11
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	10

Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12. Primary · Assesment at week 12 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	1
Part I - BI 50 mg (Fasted)	3
Part I - BI 100 mg (Fasted)	2
Part I - BI 200 mg (Fasted)	11
Part II - Placebo (Fed)	0
Part II - BI 400 mg Once Daily (Fed)	11
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	10

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12 Secondary · Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 50 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. 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. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50% reductio

Group	Value	95% CI
Part I - Placebo (Fasted)	1
Part I - BI 25 mg (Fasted)	2
Part I - BI 50 mg (Fasted)	10
Part I - BI 100 mg (Fasted)	8
Part I - BI 200 mg (Fasted)	20
Part II - Placebo (Fed)	1
Part II - BI 400 mg Once Daily (Fed)	24
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	19

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12 Secondary · Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 90 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. 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. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 90 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reductio

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	0
Part I - BI 50 mg (Fasted)	2
Part I - BI 100 mg (Fasted)	1
Part I - BI 200 mg (Fasted)	7
Part II - Placebo (Fed)	0
Part II - BI 400 mg Once Daily (Fed)	4
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	2

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12 Secondary · Assesment at week 12 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 100 at week 12. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. 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. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 100 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 100% reduc

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	0
Part I - BI 50 mg (Fasted)	0
Part I - BI 100 mg (Fasted)	1
Part I - BI 200 mg (Fasted)	2
Part II - Placebo (Fed)	0
Part II - BI 400 mg Once Daily (Fed)	1
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	2

Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24 Secondary · Assesment at week 16, 20 and 24 of treatment

Number of patients who achieved Psoriasis Area Severity Index score (PASI) 75 at weeks 16, 20 and 24. The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72. 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. Higher scores indicating higher severity, while a score of 0 indicates no disease. PASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an

Week 16

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	1
Part I - BI 50 mg (Fasted)	1
Part I - BI 100 mg (Fasted)	5
Part I - BI 200 mg (Fasted)	11

Week 20

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	2
Part I - BI 50 mg (Fasted)	3
Part I - BI 100 mg (Fasted)	4
Part I - BI 200 mg (Fasted)	13

Week 24

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	2
Part I - BI 50 mg (Fasted)	4
Part I - BI 100 mg (Fasted)	4
Part I - BI 200 mg (Fasted)	14

Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12 Secondary · Assesment at week 12 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' (sPGA 0) at Week 12. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	0
Part I - BI 50 mg (Fasted)	0
Part I - BI 100 mg (Fasted)	1
Part I - BI 200 mg (Fasted)	2
Part II - Placebo (Fed)	0
Part II - BI 400 mg Once Daily (Fed)	1
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	1

Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24 Secondary · Assesment at week 16, 20 and 24 of treatment

Number of patients who achieved a static Physician's Global Assessment score of 'clear' or 'almost clear' (sPGA 0/1) at Week 16, 20 and 24. The sPGA used in this trial is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the subject's previous disease states, whether at Baseline or at a previous visit. A lower score indicates less body coverage, with 0 being

Week 16

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	1
Part I - BI 50 mg (Fasted)	2
Part I - BI 100 mg (Fasted)	3
Part I - BI 200 mg (Fasted)	12

Week 20

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	1
Part I - BI 50 mg (Fasted)	4
Part I - BI 100 mg (Fasted)	2
Part I - BI 200 mg (Fasted)	10

Week 24

Group	Value	95% CI
Part I - Placebo (Fasted)	0
Part I - BI 25 mg (Fasted)	1
Part I - BI 50 mg (Fasted)	3
Part I - BI 100 mg (Fasted)	4
Part I - BI 200 mg (Fasted)	13

Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12 Secondary · Assesment at week 12 of treatment

Overall change from baseline in psoriasis symptoms evaluated using the total score of the Psoriasis Symptoms Scale (PSS) at Week 12. The PSS is a four-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed for a 24 hour recall period using a 5-point verbal rating scale, the PSS score ranges from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 to

Group	Value	95% CI
Part I - Placebo (Fasted)	-0.4	± 1.0
Part I - BI 25 mg (Fasted)	0.1	± 0.7
Part I - BI 50 mg (Fasted)	0.2	± 0.7
Part I - BI 100 mg (Fasted)	2.3	± 0.7
Part I - BI 200 mg (Fasted)	3.6	± 0.7
Part II - Placebo (Fed)	0.3	± 1.2
Part II - BI 400 mg Once Daily (Fed)	3.4	± 0.6
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	3.3	± 0.6

Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12 Secondary · Assesment at week 12 of treatment

Number of patients who achieved a Dermatology Life Quality Index score of 'no effect on patient's life' (DLQI 0/1) at Week 12. The DLQI is a subject-administered, ten-question, quality of life questionnaire covering 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Item scores range from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect o

Group	Value	95% CI
Part I - Placebo (Fasted)	1
Part I - BI 25 mg (Fasted)	3
Part I - BI 50 mg (Fasted)	3
Part I - BI 100 mg (Fasted)	3
Part I - BI 200 mg (Fasted)	8
Part II - Placebo (Fed)	2
Part II - BI 400 mg Once Daily (Fed)	12
Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Part I - Period 1: start till the end of treatment in period 1 (week 12) + 7 days residual effect period, up to 13 weeks. Part I - Period 1 and 2 only: start till the end of treatment (week 24) + 7 days residual effect period, up to 25 weeks. Part II: start till the end of treatment (week 12) + 7 days residual effect period, up to 13 weeks. All-cause mortality: start of treatment till the end of treatment + 4 weeks of follow up, up to 28 weeks for Part I and up to 16 weeks for part II.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part I - Period 1 - Fasted: Placebo

Serious: 0/5 (0%)

Deaths: 0/5

Part I - Period 1 - Fasted: BI 25 mg

Serious: 0/3 (0%)

Deaths: 0/3

Part I - Period 1 - Fasted: BI 50 mg

Serious: 0/8 (0%)

Deaths: 0/8

Part I - Period 1 - Fasted: BI 100 mg

Serious: 0/6 (0%)

Deaths: 0/6

Part I - Period 1 - Fasted: BI 200 mg

Serious: 0/3 (0%)

Deaths: 0/3

Part I - Period 1 and 2 - Fasted: Placebo - BI 200 mg

Serious: 0/15 (0%)

Deaths: 0/15

Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 25 mg

Serious: 0/2 (0%)

Deaths: 0/2

Part I - Period 1 and 2 - Fasted: BI 25 mg - BI 50 mg

Serious: 2/35 (6%)

Deaths: 0/35

Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 50 mg

Serious: 0/10 (0%)

Deaths: 0/10

Part I - Period 1 and 2 - Fasted: BI 50 mg - BI 100 mg

Serious: 1/21 (5%)

Deaths: 0/21

Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 100 mg

Serious: 0/8 (0%)

Deaths: 0/8

Part I - Period 1 and 2 - Fasted: BI 100 mg - BI 200 mg

Serious: 0/25 (0%)

Deaths: 0/25

Part I - Period 1 and 2 - Fasted: BI 200 mg - BI 200 mg

Serious: 0/37 (0%)

Deaths: 0/37

Part II - Placebo (Fed)

Serious: 0/10 (0%)

Deaths: 0/10

Part II - BI 400 mg Once Daily (Fed)

Serious: 0/44 (0%)

Deaths: 0/44

Part II - BI 200 mg Twice Daily, 400 mg Total (Fed)

Serious: 0/42 (0%)

Deaths: 0/42

Serious adverse events (3 terms)

Reaction	System	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part II - Placebo (Fed)	Part II - BI 400 mg Once D…	Part II - BI 200 mg Twice …
Comminuted fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (69 terms — click to expand)

Reaction	System	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 - Fasted…	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part I - Period 1 and 2 - …	Part II - Placebo (Fed)	Part II - BI 400 mg Once D…	Part II - BI 200 mg Twice …
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Liver function test increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoacusis	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tympanic membrane perforation	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Photophobia	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Visual impairment	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diverticulum intestinal	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Food poisoning	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bacteriuria	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chlamydial infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fungal infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gingivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hand-foot-and-mouth disease	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Localised infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lyme disease	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nail avulsion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Comminuted fracture, Basal cell carcinoma, Pneumonia aspiration.

Data from ClinicalTrials.gov NCT03635099 adverse events section.

Sponsor's own description

The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment

Publications & conference data

6 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
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
Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot.
Mak BC, Addeman BT, Chen J, Papp KA, et al · · 2021 · cited 4× · PMID 36777482 · DOI 10.30953/bhty.v4.182

Verify or expand the search:

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 NCT03635099 (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: 3 August 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/NCT03635099.

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