Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
608 Q2W · 1 trial · 1 indication
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a postbaseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
| Arm | Type | Description |
|---|---|---|
| 608 160 mg W0+80 mg Q2W+80 mg Q4W | EXPERIMENTAL | Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period (12 weeks). During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W). |
| 608 160 mg Q4W+160 mg Q8W | EXPERIMENTAL | Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period (12 weeks) followed by 160mg 608 once every eight weeks (Q8W) during maintenance period. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo by subcutaneous injection during induction period and then, will be re-randomized to either receive starting dose of 160mg 608 at week 12 followed by 80mg 608 once every four weeks (Q4W) or 160mg 608 once every eight weeks (Q8W) during maintenance period. |
| Name | Type | Description |
|---|---|---|
| 608 Q2W | DRUG | 608 160 mg at week 0 + 80 mg Q2W ( 6 cycles) +80 mg Q4W during maintenance period |
| 608 Q4W | DRUG | 608 160 mg Q4W ( 3 cycles) +160 mg Q8W during maintenance period |
| Placebo | DRUG | Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products. |
Inclusion Criteria: * Must be 18 Years to 75 Years, both male and female. * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization. * Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) ...
608 Q2W is an investigational small molecule being developed for the treatment of psoriasis. It is intended for patients with moderate-to-severe plaque psoriasis, a chronic skin condition characterized by inflamed, scaly patches. The drug is currently in clinical development and has not been approved by regulatory authorities.
608 Q2W is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of psoriasis.
608 Q2W is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The Phase 3 trial for 608 Q2W has been completed, and the results will determine whether further development or regulatory submission is pursued.
608 Q2W has been studied in one completed Phase 3 clinical trial registered as NCT05536726. This randomized, double-blind, placebo-controlled study enrolled 458 participants in China with moderate-to-severe plaque psoriasis. The trial evaluated the drug's safety and efficacy in this patient population.
No, 608 Q2W is a small molecule, not a monoclonal antibody. Although the clinical trial title references a recombinant anti-IL-17A humanized monoclonal antibody, the drug 608 Q2W itself is classified as a small molecule. The trial was designed to compare the drug against placebo in patients with psoriasis.