JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers

Clinical and Translational Medicine

Table 2 Overview of AEs in the idiopathic pulmonary fibrosis study

Double-blind treatment period, patients, n (%)	Placebo^a n = 5	CC-930
Double-blind treatment period, patients, n (%)	Placebo^a n = 5	50 mg QD n = 8	100 mg QD n = 8	100 mg BID n = 7	Total N = 28
≥1 AE	3 (60.0)	1 (12.5)	5 (62.5)	5 (71.4)	14 (50.0)
≥1 severe AE	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
≥1 serious AE	0 (0.0)	0 (0.0)	0 (0.0)	1 (14.3)	1 (3.6)
AE leading to drug withdrawal	0 (0.0)	0 (0.0)	1 (12.5)^b	1 (14.3)	2 (7.1)
Death	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
AE in ≥2 patients (in any treatment group)
Dizziness	0 (0.0)	0 (0.0)	2 (25.0)	2 (28.6)	4 (14.3)
Upper respiratory tract infection	0 (0.0)	0 (0.0)	1 (12.5)	1 (14.3)	2 (7.1)
Headache	0 (0.0)	0 (0.0)	2 (25.0)	0 (0.0)	2 (7.1)
Nausea	0 (0.0)	0 (0.0)	2 (25.0)	0 (0.0)	2 (7.1)

CC-930 exposure period, patients, n (%)	CC-930			Total N = 28
CC-930 exposure period, patients, n (%)	50 mg QD n = 10	100 mg QD n = 10	100 mg BID n = 8	Total N = 28
≥1 AE	7 (70.0)	9 (90.0)	8 (100.0)	24 (85.7)
≥1 severe AE	0 (0.0)	2 (20.0)	1 (12.5)	3 (10.7)
≥1 serious AE	0 (0.0)	1 (10.0)	2 (25.0)	3 (10.7)
AE leading to drug withdrawal	2 (20.0)	5 (50.0)	6 (75.0)	13 (46.4)
Death	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
AE in ≥2 patients (in any treatment group)
Increased alanine aminotransferase	0 (0.0)	1 (10.0)	5 (62.5)	6 (21.4)
Increased aspartate aminotransferase	0 (0.0)	1 (10.0)	5 (62.5)	6 (21.4)
Upper respiratory tract infection	2 (20.0)	2 (20.0)	2 (25.0)	6 (21.4)
Increased blood lactate dehydrogenase	0 (0.0)	0 (0.0)	4 (50.0)	4 (14.3)
Bronchitis	2 (20.0)	2 (20.0)	0 (0.0)	4 (14.3)
Nasopharyngitis	1 (10.0)	2 (20.0)	1 (12.5)	4 (14.3)
Dizziness	0 (0.0)	2 (20.0)	2 (25.0)	4 (14.3)
Headache	1 (10.0)	2 (20.0)	0 (0.0)	3 (10.7)
Sinusitis	1 (10.0)	1 (10.0)	1 (12.5)	3 (10.7)
Diarrhea	0 (0.0)	3 (30.0)	0 (0.0)	3 (10.7)
Nausea	0 (0.0)	2 (20.0)	0 (0.0)	2 (7.1)
Viral gastroenteritis	0 (0.0)	1 (10.0)	1 (12.5)	2 (7.1)
Increased C-reactive protein	0 (0.0)	2 (20.0)	0 (0.0)	2 (7.1)
Muscle spasms	0 (0.0)	1 (10.0)	1 (12.5)	2 (7.1)
Musculoskeletal chest pain	0 (0.0)	2 (20.0)	0 (0.0)	2 (7.1)
Rash	1 (10.0)	0 (0.0)	1 (12.5)	2 (7.1)
Cough	1 (10.0)	1 (10.0)	0 (0.0)	2 (7.1)
Productive cough	1 (10.0)	0 (0.0)	1 (12.5)	2 (7.1)

AE adverse event; ALT alanine aminotransferase; AST increased aspartate aminotransferase
^aIncludes placebo patients from groups receiving CC-930 50 mg QD, 100 mg QD, and 100 mg BID
^bPatient discontinued after completing the double-blind treatment phase but before enrolling in the open-label treatment phase