Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06122649 | A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO) | PHASE3 | COMPLETED | 203 | — | — | Nov 27, 2023 | Dec 5, 2025 | Jan 5, 2026 | 21 | China |
| NCT06088199 | A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 51 | — | — | Oct 24, 2023 | Aug 6, 2026 | Nov 17, 2025 | 30 | United States |
| NCT05565560 | A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 17 | — | — | Jan 25, 2023 | Sep 6, 2026 | Dec 19, 2025 | 29 | Japan |
| NCT03930186 | A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy | PHASE3 | COMPLETED | 152 | — | — | Jun 17, 2019 | Sep 25, 2020 | Jan 20, 2022 | 56 | Germany, Japan |
| NCT01232283 | Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. | PHASE3 | COMPLETED | 413 | — | — | Nov 22, 2010 | Nov 30, 2016 | Mar 15, 2022 | 46 | United States, Austria +7 |
| NCT01194219 | Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 844 | — | — | Sep 9, 2010 | Nov 22, 2016 | Mar 15, 2022 | - | — |
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. 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 PASI score was set to missing if any severity score or degree of involvement is missing.
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. 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 PASI score was set to missing if any severity score or degree of involvement is missing.
| Arm | Type | Description |
|---|---|---|
| Placebo-controlled Treatment Phas | EXPERIMENTAL | Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. |
| Active Treatment Phase | EXPERIMENTAL | Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks. |
| Apremilast | EXPERIMENTAL | Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink. |
| Placebo | PLACEBO_COMPARATOR | Participants will be initially randomized to placebo, identically matching during Weeks 0-16. At Week 16, Placebo participants will be switched to receive apremilast 30 mg BID. All participants will maintain Apremilast dosing through Week 32. At Week 32, participants originally randomized to placebo at baseline (Week 0) and are considered non-responders i( \< PASI-50) will have the option of adding topical therapies and/or phototherapy to their Apremilast treatment regimen. At Week 52, all participants will continue treatment with apremilast 30 mg BID. Participants will be followed and evaluated for safety and efficacy for up to an additional 4 years (years 2 through 5). |
| Apremilast 30 mg | ACTIVE_COMPARATOR | Apremilast 30 mg by mouth (PO) twice a day (BID). Participants initially randomized to apremilast 30 mg BID, and who were able to demonstrate a Psoriasis Area Severity Index (PASI) -75 response at week 32 were randomized (1 to 1) to either apremilast 30 mg BID or oral placebo (until effect is lost). At relapse/loss of response to therapy prior to Week 52 (the time at which 75% improvement in PASI score compared to baseline was lost) or at Week 52, participants were re-treated with apremilast 30 mg BID for the duration of their participation in the study. Non-responders or partial responders (PASI response \<75) received additional topical therapies or phototherapy beginning at Week 32. |
| Name | Type | Description |
|---|---|---|
| apremilast | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
| Topical Therapy | DRUG | Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician. |
| Topical or Phototherapy Therapy | OTHER | Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit. |
| Topical treatments or phototherapy | DRUG | At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen. |
Inclusion Criteria * Chinese participants aged ≥18. * Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0). * Participant is a candida...