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Fumaderm · 1 trial · 1 indication
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
| Arm | Type | Description |
|---|---|---|
| Risankizumab | EXPERIMENTAL | Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16. |
| Fumaderm | ACTIVE_COMPARATOR | Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows. |
| Name | Type | Description |
|---|---|---|
| Fumaderm | DRUG | Fumaderm tablet administered orally |
| risankizumab | DRUG | Risankizumab administered by subcutaneous (SC) injection |
Inclusion Criteria: * Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant * Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis...
Fumaderm is an investigational small molecule being studied for the treatment of moderate to severe plaque psoriasis in adults. It is being evaluated in patients who are naïve to and candidates for systemic therapy. The drug is currently in Phase 3 clinical development for this dermatological condition.
Fumaderm is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to assess the drug's efficacy in patients with moderate to severe plaque psoriasis.
Fumaderm is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for the treatment of moderate to severe plaque psoriasis.
Fumaderm has been studied in one completed Phase 3 clinical trial with the identifier NCT03255382. This trial enrolled 120 participants in Germany and assessed the efficacy of Fumaderm compared to risankizumab in subjects with moderate to severe plaque psoriasis who were naïve to and candidates for systemic therapy.
No, Fumaderm is not the same as risankizumab. Fumaderm is the investigational drug being studied in a clinical trial, while risankizumab is the active comparator used in that trial. The study was designed to assess the efficacy of Fumaderm compared to risankizumab in patients with moderate to severe plaque psoriasis.