A Phase 1 interventional study of BAY1834845 and Matching Placebo in Healthy Volunteers and Psoriasis, sponsored by Bayer. Completed at 2 sites in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-26.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
Among 299 studies in Psoriasis with a site in Germany — 13 open to participants now, 30 under way, 15 of them phase 3. Psoriasis · Germany.
Among the 299 studies in Psoriasis with a site in Germany, this one is the 182nd largest by enrollment of the 260 interventional ones that give a count, is one of 28 that started in 2018, is one of 26 in phase 1, and was the 195th registered.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
Browse Psoriasis studies →13 of the 299 studies in Psoriasis with a site in Germany are open now. Recruiting first, the newest first:
Takeda · Sites in Germany, United States, China and 4 more countries
Ages 4–17
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 13 more countries
Ages 12–17
UCB Biopharma SRL · Sites in Germany, United States, Canada and 10 more countries
Ages 18+
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 22 more countries
Ages 40+
LEO Pharma · Sites in Germany, United States, Canada and 2 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
299 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 83 · Phase 3 122 · Phase 4 23
First in 2000; this study’s year is marked. 28 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 72 is close to the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Median enrollment 195 across the 260 interventional studies, 588 across the 39 observational. Of the 264 that completed or were terminated, 160 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
274 of 299 have an industry lead sponsor. The 10 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Bayer has 4 studies filed under Psoriasis — fewer than ten, so there is no comparison to draw.
2 of the studies in Psoriasis with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013201LEO PharmaA 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis | 2027-06-04 |
| NCT03886246LEO PharmaEffisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study | 2027-09-30 |
Among the 299 studies in Psoriasis with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).
To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1 (healthy male subjects)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)
Drug: BAY1834845 · Drug: Midazolam
Part 1: Matching placebo in healthy male subjects.
Other: Matching Placebo · Drug: Midazolam
Part 2: This dose level will be adminstered in female and male patients with psoriasis
Drug: BAY1834845
Part 2: The placebo will be adminstered in female and male patients with psoriasis
Other: Matching Placebo
Orally administered.
Orally administered.
Part 1: Orally administered 1mg as a single dose.
Frequency of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Time frame: Approximately 47 days
Severity of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Time frame: Approximately 47 days
Frequency of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Time frame: Approximately 84 days
Severity of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Time frame: Approximately 84 days
AUC(0-24)md of BAY1834845
Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
AUC(0-12)md of BAY1834845
Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Cmax,md of BAY1834845
Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Cav,md of BAY1834845
Part 1 Cav:Average concentration within a dosing interval after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
AUC(0-24)md of BAY1834845
Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Time frame: Part 2: one day between day 35 and 42
AUC(0-12)md of BAY1834845
Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing
Time frame: Part 2: one day between day 35 and 42
Cmax,md of BAY1834845
Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
Time frame: Part 2: one day between day 35 and 42
Cav, md of BAY1834845
Part 2: Cav: Average concentration within a dosing interval after multiple dosing
Time frame: Part 2: one day between day 35 and 42
Ran from Apr 2018 to primary completion in Sep 2020, 29 months.
Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 29 months is above that.
Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Zabedosertib · Midazolam