The findings of the phase 3 trial highlight the potential of the Rxolitinib cream (opzelura) 1.5% as topical treatment for Priguro Nodularis (PN), which shows a significant relief of itching and the improvement of the skin in patients.
True phase 3 clinical trial studies of INCyTE, TRUE-PN1 and TRUE-PN2, evaluated the safety and efficacy of the cream twice a day, a JAK1/2 inhibitor, in adult patients with PN.
The TRUE-PN1 study with its primary final point, demonstrating that significantly more patients with PNs that applied 1.5% versus vehicle control of the vehicle to an improvement ≥4 points from the beginning in the sausage) to 124.4 SALUAL SALE SCALIFICATION SCALE SCALE 20.6%; Significant improvements were observed with itching with 1.5% versus vehicle control of the vehicle on day 7 (22.4% vs 8.0%; p = 0.0064), with numerical improvements versus vehicle control informed at previous time points.
In addition, the TRUE-P1 study with all key secondary final points, which include:
- Significantly more patients who applied Rxolitinib 1.5% versus vehicle control achieved the global evaluation of a researcher for the stage of chronic priguro treatment (IGA-CPG-SS) in week 12 (15.8% US 3.9%; p = 0.0048).
- As a result, significant Ly patients who applied the Rxolitinib 1.5% versus vehicle control achieved the general success of treatment (11.9% compared to 2.9%; p = 0.0164), defined by patients who achieved the Wi-TS4 response and an IGA-NRS4; And, and,
- Significantly more patients treated with 1.5% Raxolitinib cream versus vehicle control also achieved Wi-NRS4 in week 4 (29.7% compared to 12.7%, p = 0.0034).
“PN is a challenging condition characterized by nodules intensely with itching that significantly impact the quality of life of patients,” says Jim Lee, MD, PHD, group vice president of inflammation and selfimmunity in Incyte in Incyte, resulting in people with “PN and PN”.
Positive trend through secondary end points
In addition, the upper line data of the phase 3 clinical test 3 TRUE-PN2 demonstrated a strong positive trend at all key secondary final points, partly for IGA-CPG-STS in week 12 and Wirs4 ATHY 7 (nominal P value). While the main end point was in favor of Rxolitinib 1.5% versus the vehicle, it did not reach statistical significance due to the high placebo response. TRUE-PN2 study data will be sent for presentation at an upcoming scientific meeting.
The General Security Profile of Rxolitinib 1.5% in the TRU-PN Clinical Test Program is consistent with previous data, and no new safety signals were observed.
“This program includes the first clinical trials that evaluate a topical cat inhibitor for the treatment of PN patients, a condition associated with the formation of cutaneous nodules throughout the body that cause persistent itching and professor of Joawna and president of dermatology at the University of Maryland School of Medicine and Head of Service Dermatology at the Medical Center of the University of Maryland, in a liberation.” Itching and pn lesions, and I think it has the potential to be a very necessary novel approach for PN patients. ”
The results of the TRUE-P1 and TRUE-PN2 studies will report the planned discussions with the regulatory authorities to determine the next steps.
The 1.5% Rxolitinib cream (Opzelura) was approved by the US Food and Medicines Administration. respectively.
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