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ixekizumab Dosing Regimen · 1 trial · 1 indication
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
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 separately 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). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
| Arm | Type | Description |
|---|---|---|
| 80 mg ixekizumab Dosing Regimen 1 | EXPERIMENTAL | Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2. |
| 80 mg ixekizumab Dosing Regimen 2 | EXPERIMENTAL | Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2. |
| 80 mg ixekizumab Dosing Regimen 3 | EXPERIMENTAL | Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3. |
| 50 mg etanercept | ACTIVE_COMPARATOR | Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2. |
| Placebo for ixekizumab | PLACEBO_COMPARATOR | Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups. |
| Name | Type | Description |
|---|---|---|
| 80 mg ixekizumab Dosing Regimen | DRUG | Administered SC |
| 50 mg etanercept | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug * At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug * Static Physician Global A...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 5 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
Ixekizumab Dosing Regimen is used for the treatment of moderate to severe psoriasis. It is a monoclonal antibody developed by Eli Lilly and Company. The regimen has been studied in a Phase 3 clinical trial in adults with this condition.
Ixekizumab Dosing Regimen targets interleukin-17A (IL-17A). It is an inhibitor of this cytokine, which plays a role in inflammatory processes associated with psoriasis. By targeting IL-17A, the drug aims to reduce inflammation and improve skin symptoms.
Ixekizumab Dosing Regimen is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. The company is responsible for the clinical development and potential commercialization of this treatment.
Ixekizumab Dosing Regimen is in Phase 3 clinical development. It is an investigational treatment and has not been approved by the FDA for any indication. The Phase 3 trial for psoriasis has been completed.
Ixekizumab Dosing Regimen has been evaluated in a Phase 3 clinical trial, NCT01597245, titled UNCOVER-2. This completed trial enrolled 1224 participants with moderate to severe psoriasis across multiple countries. It was randomized, double-blind, and placebo-controlled.