Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT05896527)
NCT ID: NCT05896527
Last Updated: 2025-04-04
Results Overview
Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
229 participants
Primary outcome timeframe
Week 12
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo tablets orally twice daily (BID) for 12 weeks.
|
DC-806 200 mg BID
Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
|
DC-806 800 mg BID
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
46
|
47
|
47
|
|
Overall Study
Received at Least One Dose of the Study Drug
|
44
|
44
|
46
|
47
|
47
|
|
Overall Study
Safety Analysis Set
|
43
|
44
|
46
|
48
|
47
|
|
Overall Study
COMPLETED
|
32
|
31
|
40
|
40
|
44
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
6
|
7
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets orally twice daily (BID) for 12 weeks.
|
DC-806 200 mg BID
Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks.
|
DC-806 800 mg BID
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
4
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
2
|
1
|
|
Overall Study
Significant protocol noncompliance
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Eligibility criteria not met
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor's decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Investigator's decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy of his partner
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Participants received placebo tablets orally twice daily for 12 weeks.
|
DC-806 200 mg BID
n=44 Participants
Participants received 200 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
n=46 Participants
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
n=47 Participants
Participants received 600 mg of DC-806 tablets orally once daily for 12 weeks.
|
DC-806 800 mg BID
n=47 Participants
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 14.24 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 12.68 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 14.25 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 13.76 • n=21 Participants
|
44.0 years
STANDARD_DEVIATION 13.51 • n=10 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
72 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
156 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
201 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
195 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of the study drug.
Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received placebo tablets orally twice daily for 12 weeks.
|
DC-806 200 mg BID
n=44 Participants
Participants received 200 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
n=46 Participants
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
n=47 Participants
Participants received 600 mg of DC-806 tablets orally once daily for 12 weeks.
|
DC-806 800 mg BID
n=47 Participants
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
|
13.6 percentage of participants
|
6.8 percentage of participants
|
21.7 percentage of participants
|
17 percentage of participants
|
36.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through End of follow-up (Up to 16 weeks)Population: All participants from the safety analyses set.
* A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug. * An SAE is any untoward medical occurrence that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received placebo tablets orally twice daily for 12 weeks.
|
DC-806 200 mg BID
n=44 Participants
Participants received 200 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
n=46 Participants
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
n=48 Participants
Participants received 600 mg of DC-806 tablets orally once daily for 12 weeks.
|
DC-806 800 mg BID
n=47 Participants
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations
TEAEs
|
12 Participants
|
19 Participants
|
20 Participants
|
22 Participants
|
27 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEASs Leading to Treatment Discontinuations
TEASs leading to treatment discontinuations
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DC-806 200 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
DC-806 400 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
DC-806 600 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
DC-806 800 mg BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Participants received placebo tablets orally twice daily for 12 weeks.
|
DC-806 200 mg BID
n=44 participants at risk
Participants received 200 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
n=46 participants at risk
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
n=48 participants at risk
Participants received 600 mg of DC-806 tablets orally once daily for 12 weeks.
|
DC-806 800 mg BID
n=47 participants at risk
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/43 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/44 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/46 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/48 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
2.1%
1/47 • Number of events 1 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Participants received placebo tablets orally twice daily for 12 weeks.
|
DC-806 200 mg BID
n=44 participants at risk
Participants received 200 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 400 mg BID
n=46 participants at risk
Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks.
|
DC-806 600 mg QD
n=48 participants at risk
Participants received 600 mg of DC-806 tablets orally once daily for 12 weeks.
|
DC-806 800 mg BID
n=47 participants at risk
Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
2.3%
1/44 • Number of events 1 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/46 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
4.2%
2/48 • Number of events 2 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
6.4%
3/47 • Number of events 5 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/44 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/46 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
6.2%
3/48 • Number of events 3 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
4.3%
2/47 • Number of events 3 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/44 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
0.00%
0/46 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
2.1%
1/48 • Number of events 1 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
6.4%
3/47 • Number of events 3 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
2/43 • Number of events 2 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
4.5%
2/44 • Number of events 2 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
2.2%
1/46 • Number of events 1 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
14.6%
7/48 • Number of events 9 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
2.1%
1/47 • Number of events 1 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
3/43 • Number of events 4 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
15.9%
7/44 • Number of events 8 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
10.9%
5/46 • Number of events 5 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
8.3%
4/48 • Number of events 4 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
6.4%
3/47 • Number of events 3 • Baseline through End of follow-up (Up to 16 weeks)
All participants from the safety analyses set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60