Where acceptance is all there is
I've been watching the trial for the drug by Concert Pharma called CTP-543. It hasn't started in my area but according to the governmt website they are started in a few places: https://clinicaltrials.gov/ct2/show/NCT03137381?term=ctp-543&ra... Rancho Mirage, New Haven (CT), Portland, Houston and a couple other places. Anyone lucky enough to get on the study yet? It's a newer version of Rux.
Bonjour return life j'ai besoin de ton aide j'ai eu une constipation et mon estomac va pas bien .
Je ne suis plus constipé mais j'ai une mauvaise sensation à l'estomac .
Si tu a deja eu cela
Have you started this sadele ?
If you have? Have you had any good results ? I know this has been fast tracked now
hey how are you
Company On Track to Report Topline Data from the 4 mg and 8 mg Twice-Daily Cohorts in Fourth Quarter of 2018
LEXINGTON, Mass.--(BUSINESS WIRE)--Sep. 26, 2018-- Concert Pharmaceuticals, Inc.(NASDAQ: CNCE) today announced that it will include an additional cohort of patients in the Phase 2a trial evaluating CTP-543. The protocol amendment provides for additional patients to be enrolled in the trial in order to evaluate a 12 mg dose of CTP-543 or placebo twice daily for 24 weeks. In the third quarter of 2018, an independent Data Monitoring Committee (DMC) conducted a planned interim safety data review after patients in the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice daily for at least 12 weeks. Based on this review, the DMC provided its recommendation to continue with the current 8 mg cohort to completion and also provided support for an additional cohort to evaluate the 12 mg dose twice daily. The Company has initiated enrollment in the 12 mg cohort. The Company also expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in the fourth quarter of 2018.
“We believe that understanding a broader dose range in the Phase 2a trial will be important to our selection of the CTP-543 doses for late stage clinical development,” stated James Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. “We are grateful for the patient community’s support of the CTP-543 development program, as we work at the forefront of exploring new treatment options for patients with our oral JAK inhibitor for the treatment of alopecia areata.”
The Phase 2a trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. With the protocol amendment, patients are randomized to receive one of three doses of CTP-543 (4 mg, 8 mg, or 12 mg) or placebo twice daily. Enrollment in the 4 mg and 8 mg cohorts is complete and enrollment in the 12 mg cohort is ongoing. The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. Additional information about the trial is available on www.clinicaltrials.gov.
About CTP-543 and Alopecia Areata
CTP-543 was discovered by applying Concert's deuterium chemistry technology to modify ruxolitinib, a drug which selectively inhibits Janus kinases 1 and 2 (JAK1 and JAK2) and is commercially available under the name Jakafi® in the United States for the treatment of certain blood disorders. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been reported to promote hair growth in individuals with moderate-to-severe disease. Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543.
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body that may affect up to 650,000 Americans at any given time1. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata.
The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the U.S. Food and Drug Administration’s (FDA) Patient-Focused Drug Development meeting held in September 2017 on alopecia areata, the FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. Additional information on the PFDDI is available online.
New press release from concert
CTP-543 Achieved its Primary Endpoint in the 8 mg and 12 mg Twice-Daily Dosing Cohorts
Advancement into Phase 3 Evaluation Planned in 2020
Company to Host Investor Conference Call Today at 8:30 a.m. ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Sep. 3, 2019-- Concert Pharmaceuticals, Inc.(NASDAQ: CNCE) today announced final topline results from its recently completed dose-ranging Phase 2 trial evaluating its investigational medicine CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss. Patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool (SALT). The 8 mg twice-daily and 12 mg twice-daily groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT from baseline at 24 weeks. At Week 24, patients treated with 8 mg twice-daily and 12 mg twice-daily compared to placebo also rated significantly greater improvement in their alopecia areata on the Patient Global Impression of Improvement Scale. Treatment with CTP-543 was generally well tolerated. Complete study results are expected to be presented at a future medical meeting.
“We are very pleased with these clinical results and continue to believe CTP-543 has potential to be a best-in-class treatment for alopecia areata, a chronic dermatological autoimmune disease that currently has no approved therapies,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. “We are highly focused on the need for an effective and safe treatment for alopecia areata, and we plan to advance CTP-543 into Phase 3 testing next year.”
“These Phase 2 results of CTP-543, a Janus kinase or JAK inhibitor, for the treatment of patients with alopecia areata are highly encouraging,” stated Dr. Brett King, Associate Professor of Dermatology at Yale School of Medicine. “There is a growing body of evidence supporting JAKs as a target for the treatment of alopecia areata that is driving enthusiasm in dermatology to address an important unmet need for patients.”
The primary efficacy endpoint in the 12 mg twice-daily cohort was met with 58% of patients achieving a ≥ 50% relative reduction in their overall SALT score from baseline compared to 9% for placebo (p <0.001). In the 8 mg twice-daily cohort, 47% of patients achieved the primary endpoint compared to placebo (p <0.001). For the 4 mg cohort, 21% of patients achieved a ≥ 50% relative reduction in their overall SALT score from baseline, however these differences were not significantly different from placebo. In addition, 78% of the patients receiving 12 mg twice-daily and 58% of the patients receiving 8 mg twice-daily rated their alopecia areata as “much improved” or “very much improved” at 24 weeks of dosing, a significant difference from placebo.
The average baseline SALT score across all patients was approximately 88%, where 0% is no scalp hair loss and 100% represents total scalp hair loss. The most common (≥10%) side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection, and acne. One serious adverse event of facial cellulitis was reported as possibly related to treatment; however, after a brief interruption, treatment was continued and this patient completed the trial. No thromboembolic events were reported during the trial.
The Phase 2 trial was a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. A total of 149 patients were randomized to receive one of three doses of CTP-543 (4 mg, 8 mg, or 12 mg) or placebo, administered twice-daily. The primary outcome measure utilized the SALT score after 24 weeks of dosing. All patients who completed 24 weeks of treatment in the 12 mg dosing cohort had the opportunity to continue in a separate extension study to evaluate long-term safety and efficacy of CTP-543.
I am 4 weeks in on the 12mg trial, I can see little white hairs in spots that have been bald for quite some time. Its still a little soon but I think the little progress is very promising. Is anyone else on this trial?
yes! i am 6 weeks in and am also seeing a bit of vellus on the top.
Awesome!!! Have you seen the most recent publications by concert? Regrowth has been quiet amazing at 12 and 24 weeks
yes i saw that! But I am trying to be patient and manage my expectations. I have had AA on and off for 20 years so you'd think I would have the patience of a saint by now but was super excited to get on the study.
Yeah I know what you mean, I’ve had it for 16 years now, so I’m trying to not get my hopes up, hopefully it works out :)