First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes

Table 2 Summary of adverse events — safety analysis set

AEs, n (%) [number of events]	Placebo (n = 10)	IMCY-0098 dose A (n = 6)	IMCY-0098 dose B (n = 9)	IMCY-0098 dose C (n = 16)	Total (N = 41)
All AEs	9 (90.0) [51]	6 (100) [38]	9 (100) [85]	16 (100) [141]	40 (97.6) [315]
Solicited AEs	7 (70.0) [24]	3 (50.0) [19]	7 (77.8) [40]	12 (75.0) [72]	29 (70.7) [156]
Unsolicited AEs	8 (80.0) [27]	6 (100) [19]	9 (100) [43]	16 (100) [69]	39 (95.1) [159]
AEs by grade
Grade 1	5 (50.0)	5 (83.3)	4 (44.4)	6 (37.5)	20 (48.8)
Grade 2	3 (30.0)	1 (16.7)	5 (55.6)	10 (62.5)	19 (46.3)
Grade 3	1 (10.0)	0	0	0	1 (2.4)
Grade 4	0	0	0	0	0
Treatment-related AEs	6 (60.0) [25]	4 (66.7) [18]	7 (77.8) [41]	11 (68.8) [65]	28 (68.3) [150]
Injection site reactions	5 (50.0) [18]	3 (50.0) [12]	4 (44.4) [26]	8 (50.0) [50]	20 (48.8) [106]
Injection site pain	3 (30.0) [3]	3 (50.0) [9]	3 (33.3) [8]	6 (37.5) [28]	15 (36.6) [47]
Injection site erythema	3 (30.0) [11]	1 (16.7) [1]	2 (22.2) [9]	4 (25.0) [6]	10 (24.4) [27]
Injection site induration	1 (10.0) [1]	0	1 (11.1) [4]	3 (18.8) [5]	5 (12.2) [10]
Injection site pruritus	1 (10.0) [1]	1 (16.7) [1]	1 (11.1) [3]	2 (12.5) [4]	5 (12.2) [9]
Injection site swelling	0	1 (16.7) [1]	1 (11.1) [1]	2 (12.5) [3]	4 (9.8) [5]
Injection site bruising	0	0	1 (11.1) [1]	3 (18.8) [3]	4 (9.8) [4]
Injection site reaction	1 (10.0) [2]	0	0	0	1 (2.4) [2]
Injection site irritation	0	0	0	1 (6.3) [1]	1 (2.4) [1]
SAEs	0	0	1 (11.1) [2]^a	1 (6.3) [1]	2 (4.9) [3]
Phimosis	0	0	1 (11.1) [1]	0	1 (2.4) [1]
Varicocele	0	0	1 (11.1) [1]	0	1 (2.4) [1]
Vestibular neuronitis	0	0	0	1 (6.3) [1]	1 (2.4) [1]
AEs leading to drug withdrawal	0	0	0	0	0
AEs leading to death	0	0	0	0	0

Dose A: 50 μg at week 0 followed by 3 × 25 μg; dose B: 150 μg at week 0 followed by 3 × 75 μg; dose C: 450 μg at week 0 followed by 3 × 225 μg
AE adverse event, SAE serious adverse event
^aBoth SAEs occurred in the same patient and were associated with surgery for a pre-existing condition
Solicited AEs included a selection of specific AE terms listed in the case report form and patient’s diary card (injection site reactions and systemic reactions, such as headache, fatigue, malaise, myalgia, and fever). Unsolicited AEs included any events that were not listed and any solicited AEs that occurred outside of the 7-day follow-up period. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) approach defined by the US Department of Health and Human Services [30]. Both solicited and unsolicited AEs were evaluated for their relationship to study treatment. Treatment-related AEs were defined as those that were possibly related (unlikely related but could not be ruled out) or probably related (considered related with a high degree of certainty) to the study product

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