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- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Nov 29, 2022
P1, N=16, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Nov 29, 2022
P1, N=21, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Oct 31, 2022
P1, N=16, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Oct 31, 2022
P1, N=21, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||||| Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (clinicaltrials.gov) - Sep 29, 2022
P3, N=517, Completed, Sponsor: Concert Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects (clinicaltrials.gov) - Aug 30, 2022
P1, N=18, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Completed
- ruxolitinib deuterated (CTP-543) / Concert Pharma
Top-line results from THRIVE-AA1: A clinical trial of CTP-543 (Deuruxolitinib), an oral JAK inhibitor, in adult patients with moderate to severe alopecia areata (Golden Plenary) - Aug 25, 2022 - Abstract #EADV2022EADV_3278;
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects (clinicaltrials.gov) - Jul 28, 2022
P1, N=18, Recruiting, Sponsor: Concert Pharmaceuticals
- || ruxolitinib deuterated (CTP-543) / Concert Pharma
Clinical, P2 data, Journal: Phase 2 Randomized, Dose-Ranging Trial of CTP-543, a Selective Janus Kinase Inhibitor, in Moderate to Severe Alopecia Areata. (Pubmed Central) - Jul 23, 2022
Recruiting --> Completed Patients treated with CTP-543 (8 or 12 mg, twice daily) had a significant reduction in the severity of AA.
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Jul 21, 2022
P1, N=16, Recruiting, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers (clinicaltrials.gov) - Jul 20, 2022
P1, N=16, Completed, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects (clinicaltrials.gov) - Jul 20, 2022
P1, N=20, Completed, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 (clinicaltrials.gov) - Jul 20, 2022
P1, N=22, Recruiting, Sponsor: Concert Pharmaceuticals
- ||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults with Alopecia Areata (clinicaltrials.gov) - Jul 1, 2022
P3, N=300, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Patients treated with CTP-543 (8 or 12 mg, twice daily) had a significant reduction in the severity of AA. Enrolling by invitation --> Active, not recruiting
- ||||||| Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (clinicaltrials.gov) - Jun 15, 2022
P3, N=706, Completed, Sponsor: Concert Pharmaceuticals
Enrolling by invitation --> Active, not recruiting Active, not recruiting --> Completed
- |||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment status: Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Jun 3, 2022
P2/3, N=1000, Enrolling by invitation, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Enrolling by invitation
- |||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment status: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults with Alopecia Areata (clinicaltrials.gov) - Jun 3, 2022
P3, N=300, Enrolling by invitation, Sponsor: Concert Pharmaceuticals
Recruiting --> Enrolling by invitation Recruiting --> Enrolling by invitation
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers (clinicaltrials.gov) - Mar 4, 2022
P1, N=48, Completed, Sponsor: Concert Pharmaceuticals
Recruiting --> Enrolling by invitation Active, not recruiting --> Completed
- || Olumiant (baricitinib) / Incyte, Eli Lilly
Clinical, P2 data, Journal: Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study. (Pubmed Central) - Mar 1, 2022
P2/3
Active, not recruiting --> Completed These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss.
- ||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - Feb 16, 2022
P2, N=300, Active, not recruiting, Sponsor: Concert Pharmaceuticals
These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss. Recruiting --> Active, not recruiting
- ||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (clinicaltrials.gov) - Jan 21, 2022
P3, N=517, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers (clinicaltrials.gov) - Jan 13, 2022
P1, N=48, Active, not recruiting, Sponsor: Concert Pharmaceuticals
- ||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed, Trial completion date: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (clinicaltrials.gov) - Nov 5, 2021
P3, N=708, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jun 2022
- |||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults with Alopecia Areata (clinicaltrials.gov) - Oct 27, 2021
P3, N=300, Recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Jun 2022 Not yet recruiting --> Recruiting
- ||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment change: Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Sep 16, 2021
P2/3, N=1000, Recruiting, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Recruiting N=142 --> 1000
- |||||||||| Leqselvi (deuruxolitinib) / Sun Pharma
New P3 trial: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults with Alopecia Areata (clinicaltrials.gov) - Sep 12, 2021
P3, N=300, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects (clinicaltrials.gov) - Jul 20, 2021
P1, N=22, Completed, Sponsor: Concert Pharmaceuticals
N=142 --> 1000 Recruiting --> Completed
- |||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (clinicaltrials.gov) - Jun 1, 2021
P3, N=440, Recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Completed Not yet recruiting --> Recruiting
- || Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open: Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects (clinicaltrials.gov) - May 24, 2021
P1, N=22, Recruiting, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open, Phase classification, Trial completion date, Trial primary completion date: Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - May 17, 2021
P2/3, N=142, Recruiting, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting | Phase classification: P2 --> P2/3 | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects (clinicaltrials.gov) - Apr 12, 2021
P1, N=22, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects (clinicaltrials.gov) - Apr 7, 2021
P1, N=22, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Recruiting | Phase classification: P2 --> P2/3 | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Feb 2022 --> Feb 2023 Recruiting --> Completed
- |||||||||| Leqselvi (deuruxolitinib) / Sun Pharma
New P3 trial: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (clinicaltrials.gov) - Mar 15, 2021
P3, N=440, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- ||||| Leqselvi (deuruxolitinib) / Sun Pharma
New P2 trial: A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - Mar 4, 2021
P2, N=300, Recruiting, Sponsor: Concert Pharmaceuticals
- || Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open: Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects (clinicaltrials.gov) - Mar 2, 2021
P1, N=22, Recruiting, Sponsor: Concert Pharmaceuticals
Recruiting --> Completed Not yet recruiting --> Recruiting
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects (clinicaltrials.gov) - Feb 7, 2021
P1, N=22, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- |||||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment open: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (clinicaltrials.gov) - Nov 4, 2020
P3, N=700, Recruiting, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ruxolitinib deuterated (CTP-543) / Concert Pharma
[VIRTUAL] Initial Results From a Long-Term, Open-Label Extension Study with CTP-543, an Oral Janus Kinase Inhibitor, in Patients with Moderate to Severe Alopecia Areata (Alibert) - Oct 20, 2020 - Abstract #EADV2020EADV_1075;
- |||||||||| Leqselvi (deuruxolitinib) / Sun Pharma
New P3 trial: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (clinicaltrials.gov) - Aug 19, 2020
P3, N=700, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- ||| Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Aug 12, 2020
P2, N=66, Completed, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects (clinicaltrials.gov) - Jul 16, 2020
P1, N=21, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects (clinicaltrials.gov) - Jun 15, 2020
P1, N=21, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting
- ||| Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Apr 6, 2020
P2, N=142, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Not yet recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=100 --> 142 | Trial completion date: Mar 2021 --> May 2022 | Trial primary completion date: Dec 2020 --> Feb 2022
- || ruxolitinib deuterated (CTP-543) / Concert Pharma
Concert Pharmaceuticals Announces Plans for CTP-543 Phase 3 Trials in Alopecia Areata https://t.co/FhHhVvZzJd (Twitter) - Apr 1, 2020
- || Leqselvi (deuruxolitinib) / Sun Pharma
New P1 trial: Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects (clinicaltrials.gov) - Mar 16, 2020
P1, N=22, Not yet recruiting, Sponsor: Concert Pharmaceuticals
- | Jakafi oral (ruxolitinib) / Novartis, Incyte, Xeljanz (tofacitinib) / Pfizer
Journal: JAK inhibition in the treatment of alopecia areata - a promising new dawn? (Pubmed Central) - Jan 24, 2020
Positive results in early phase 1 and phase 2 clinical trials have enabled the commencement of phase 3 clinical trials and there is now a growing sense of optimism among patients with long-standing, treatment-refractory AA. Further work is required to determine the optimal dose and treatment duration and whether maintenance therapy is universally required.
- ||| Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Dec 22, 2019
P2, N=57, Completed, Sponsor: Concert Pharmaceuticals
Further work is required to determine the optimal dose and treatment duration and whether maintenance therapy is universally required. Active, not recruiting --> Completed
- | Leqselvi (deuruxolitinib) / Sun Pharma
Trial completion: Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers (clinicaltrials.gov) - Sep 24, 2019
P1, N=6, Completed, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ruxolitinib deuterated (CTP-543) / Concert
CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata (Hall 10 Dalí) - Sep 24, 2019 - Abstract #EADV2019EADV_3498;
- | Leqselvi (deuruxolitinib) / Sun Pharma
Enrollment closed: Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - Sep 17, 2019
P2, N=66, Active, not recruiting, Sponsor: Concert Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting