Trial Outcomes & Findings for Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA (NCT NCT04247815)

Last Updated: 2023-03-29

Results Overview

Safety and tolerability reported as Adverse Events (AEs). AEs will be coded with the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. AEs will be presented by system organ class and preferred term in frequency tables.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Baseline through Day 114

Results posted on

2023-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	ATI-450 Plus Methotrexate ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Overall Study STARTED	16	3
Overall Study COMPLETED	14	2
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ATI-450 Plus Methotrexate ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATI-450 Plus Methotrexate n=16 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=3 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly	Total n=19 Participants Total of all reporting groups
Age, Customized	55.9 years STANDARD_DEVIATION 9.93 • n=5 Participants	55.3 years STANDARD_DEVIATION 6.81 • n=7 Participants	55.8 years STANDARD_DEVIATION 9.34 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	3 participants n=7 Participants	19 participants n=5 Participants
Weight (kg)	92.74 kg STANDARD_DEVIATION 25.504 • n=5 Participants	98.93 kg STANDARD_DEVIATION 14.616 • n=7 Participants	93.72 kg STANDARD_DEVIATION 23.899 • n=5 Participants
Height (cm)	166.94 cm STANDARD_DEVIATION 12.648 • n=5 Participants	164.43 cm STANDARD_DEVIATION 3.092 • n=7 Participants	166.54 cm STANDARD_DEVIATION 11.630 • n=5 Participants
BMI (kg/m2)	33.37 kg/m2 STANDARD_DEVIATION 8.829 • n=5 Participants	36.53 kg/m2 STANDARD_DEVIATION 4.737 • n=7 Participants	33.87 kg/m2 STANDARD_DEVIATION 8.298 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through Day 114

Population: The Safety population consisted of patients who receive at least 1 dose of study drug. This set was used for the safety data summaries and baseline characteristic summaries. This set was analyzed as treated.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=16 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=3 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
The Primary Outcome Measure is the Determination of the Safety and Tolerability of ATI-450 Plus Methotrexate in Patients With Moderate to Severe Rheumatoid Arthritis: Adverse Events (AEs)	8 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline through Day 114

Population: The Per-Protocol (PP) population consisted of all patients who completed their Day 84 visit and had valid hsCRP values for at least 6 of the 7 scheduled collection times. This set was analyzed as treated.

Median percent change from baseline in high sensitivity C-reactive protein (hsCRP) levels over time

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Percent Change in (hsCRP) Levels Over Time Week 1	-75.00 Percent Change from Baseline hsCRP Interval -97.3 to 11.0	-16.50 Percent Change from Baseline hsCRP Interval -34.9 to 1.9
Percent Change in (hsCRP) Levels Over Time Week 2	-72.40 Percent Change from Baseline hsCRP Interval -96.3 to 129.4	15.50 Percent Change from Baseline hsCRP Interval -66.7 to 97.7
Percent Change in (hsCRP) Levels Over Time Week 4	-51.10 Percent Change from Baseline hsCRP Interval -96.6 to 285.3	-50.20 Percent Change from Baseline hsCRP Interval -81.2 to -19.2
Percent Change in (hsCRP) Levels Over Time Week 6	-57.60 Percent Change from Baseline hsCRP Interval -96.6 to 306.2	3.00 Percent Change from Baseline hsCRP Interval -29.2 to 35.2
Percent Change in (hsCRP) Levels Over Time Week 8	-74.20 Percent Change from Baseline hsCRP Interval -92.9 to 63.3	78.50 Percent Change from Baseline hsCRP Interval 9.6 to 147.4
Percent Change in (hsCRP) Levels Over Time Week 12	-42.60 Percent Change from Baseline hsCRP Interval -97.0 to 263.7	7.30 Percent Change from Baseline hsCRP Interval -5.6 to 20.2
Percent Change in (hsCRP) Levels Over Time Follow-up	-15.60 Percent Change from Baseline hsCRP Interval -83.1 to 143.2	-40.65 Percent Change from Baseline hsCRP Interval -66.7 to -14.6

SECONDARY outcome

Timeframe: Baseline through Day 114

The Disease Activity Score using 28 joint count C-reactive protein DAS28 (CRP) consists of a composite score of the following variables: tender joint count, swollen joint count, CRP, and Patient's Global Assessment of Disease Activity score. The following equation will be used to calculate the DAS28 (CRP): DAS28 (CRP) = 0.56 √TJC28 + 0.28√SJC28 + 0.36ln(CRP +1) + 0.014×(Patient's Global Assessment of Disease Activity) + 0.96, where: * TJC28 = number of joints tender out of 28 * SJC28 = number of joints swollen out of 28 * CRP = C-reactive protein * Patient's Global Assessment of Disease Activity on a 100 mm visual analog scale (VAS) recorded by the patient Interpretation of the DAS28 (CRP) disease activity measure is on a scale of 0 to 9.4, where: \<2.6 is considered remission, ≥2.6 to \<3.2 is considered low/minimal, ≥3.2 to ≤5.1 is considered moderate, and \>5.1 is considered high/severe.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Change From Baseline in Disease Activity Score Baseline	5.72 score on a scale Standard Deviation 0.970	6.00 score on a scale Standard Deviation 0.990
Change From Baseline in Disease Activity Score Week 1	4.33 score on a scale Standard Deviation 1.611	6.15 score on a scale Standard Deviation 0.495
Change From Baseline in Disease Activity Score Week 2	4.26 score on a scale Standard Deviation 1.570	5.25 score on a scale Standard Deviation 0.354
Change From Baseline in Disease Activity Score Week 4	4.11 score on a scale Standard Deviation 1.351	5.75 score on a scale Standard Deviation 1.061
Change From Baseline in Disease Activity Score Week 6	4.25 score on a scale Standard Deviation 1.436	6.15 score on a scale Standard Deviation 0.495
Change From Baseline in Disease Activity Score Week 8	3.84 score on a scale Standard Deviation 1.383	6.20 score on a scale Standard Deviation 0.424
Change From Baseline in Disease Activity Score Week 12	3.70 score on a scale Standard Deviation 1.574	6.35 score on a scale Standard Deviation 0.212
Change From Baseline in Disease Activity Score Follow-up	4.21 score on a scale Standard Deviation 1.705	4.95 score on a scale Standard Deviation 0.495

SECONDARY outcome

Timeframe: Baseline through Day 114

Number and Percent of Patients Achieving DAS28-CRP \<2.6 over time

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Baseline	0 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 1	2 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 2	3 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 4	2 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 6	1 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 8	2 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Week 12	3 Participants	0 Participants
Number and Percent of Patients Achieving DAS28-CRP <2.6 Over Time Follow-up	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through Day 84

Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) uses integer scales to measure the severity of disease at each bone or joint of interest in the hand and wrist, with separate scores given for osteitis and synovitis. Osteitis was scored at 25 bone locations: distal radius and ulna, 8 carpal bones (trapezium, trapezoid, capitate, hamate, pisiform, scaphoid, lunate, and triquetrum, as well as the 5 metacarpal bases), 5 metacarpal heads, and 5 proximal phalangeal bases. Score Definition 0 No osteitis 1. 1-33% involvement of original articular bone 2. 34-67% involvement of original articular bone 3. 68-100% involvement of original articular bone Synovitis was scored at the following 8 joint locations: distal radioulnar joint, radiocarpal joint, intercarpal / carpometacarpal joints 2-5, and 5 metacarpophalangeal (MCP) joints. Score Definition 0 No synovitis 1. 1-33% volume enhancement 2. 34-67% volume enhancement 3. 68-100% volume enhancement

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Change From Baseline in RAMRIS Hand-Wrist Assessments (Osteitis Average)	0.97 Change in Osteitis average Standard Deviation 1.943	0.88 Change in Osteitis average Standard Deviation 1.237

SECONDARY outcome

Timeframe: Baseline through Day 84

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Change From Baseline in RAMRIS Hand-Wrist Assessments (Synovitis Average)	0.08 Change in Synovitis average Standard Deviation 1.894	1.50 Change in Synovitis average Standard Deviation 2.121

SECONDARY outcome

Timeframe: Baseline through Day 114

American College of Rheumatology (ACR) 20 will be calculated at each treatment visit and the number and percent of subjects with a 20% improvement will be tabulated at each scheduled visit.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Number and Percent of Patients Achieving ACR 20 Week 4	8 Participants	0 Participants
Number and Percent of Patients Achieving ACR 20 Week 8	8 Participants	0 Participants
Number and Percent of Patients Achieving ACR 20 Week 12	9 Participants	0 Participants
Number and Percent of Patients Achieving ACR 20 Follow-up	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline through Day 114

American College of Rheumatology (ACR) 50 will be calculated at each treatment visit and the number and percent of subjects with a 50% improvement will be tabulated at each scheduled visit.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Number and Percent of Patients Achieving ACR 50 Week 4	2 Participants	0 Participants
Number and Percent of Patients Achieving ACR 50 Week 8	4 Participants	0 Participants
Number and Percent of Patients Achieving ACR 50 Week 12	5 Participants	0 Participants
Number and Percent of Patients Achieving ACR 50 Follow-up	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through Day 114

American College of Rheumatology (ACR) 70 will be calculated at each treatment visit and the number and percent of subjects with a 70% improvement will be tabulated at each scheduled visit.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=15 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=2 Participants Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Number and Percent of Patients Achieving ACR 70 Week 4	0 Participants	0 Participants
Number and Percent of Patients Achieving ACR 70 Week 8	3 Participants	0 Participants
Number and Percent of Patients Achieving ACR 70 Week 12	3 Participants	0 Participants
Number and Percent of Patients Achieving ACR 70 Follow-up	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Day Day 84

Population: The PK population consisted of all patients who received at least 1 dose of study drug and provided at least 1 plasma concentration value. This set was analyzed as treated.

Outcome measures

Outcome measures
Measure	ATI-450 Plus Methotrexate n=16 Participants ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Assessment of ATI-450 Concentration (ng/mL) Day 84 (2 Hours Postdose)	293.00 ATI-450 concentration (ng/mL) Standard Deviation 98.643	—
Assessment of ATI-450 Concentration (ng/mL) Day 1 (2 Hours Postdose)	225.87 ATI-450 concentration (ng/mL) Standard Deviation 78.603	—
Assessment of ATI-450 Concentration (ng/mL) Day 7 (Predose)	163.97 ATI-450 concentration (ng/mL) Standard Deviation 85.538	—
Assessment of ATI-450 Concentration (ng/mL) Day 14 (Predose)	131.51 ATI-450 concentration (ng/mL) Standard Deviation 55.175	—
Assessment of ATI-450 Concentration (ng/mL) Day 28 (Predose)	135.67 ATI-450 concentration (ng/mL) Standard Deviation 84.454	—
Assessment of ATI-450 Concentration (ng/mL) Day 42 (Predose)	170.84 ATI-450 concentration (ng/mL) Standard Deviation 99.863	—
Assessment of ATI-450 Concentration (ng/mL) Day 56 (Predose)	153.45 ATI-450 concentration (ng/mL) Standard Deviation 89.092	—
Assessment of ATI-450 Concentration (ng/mL) Day 84 (Predose)	124.71 ATI-450 concentration (ng/mL) Standard Deviation 69.437	—

Adverse Events

ATI-450 Plus Methotrexate

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Plus Methotrexate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ATI-450 Plus Methotrexate n=16 participants at risk ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=3 participants at risk Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Infections and infestations COVID-19 pneumonia	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114

Other adverse events

Other adverse events
Measure	ATI-450 Plus Methotrexate n=16 participants at risk ATI-450 50mg oral tablet BID with a stable weekly dose of Methotrexate ATI-450: Oral, small molecule MK2 inhibitor Methotrexate: 7.5 mg to 25 mg weekly	Placebo Plus Methotrexate n=3 participants at risk Placebo oral tablet BID with a stable weekly dose of Methotrexate Placebo oral tablet: Placebo tablet manufactured to match ATI-450 in appearance Methotrexate: 7.5 mg to 25 mg weekly
Cardiac disorders Palpitations	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Cardiac disorders Ventricular extrasystoles	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Gastrointestinal disorders Dental caries	6.2% 1/16 • Number of events 1 • Baseline to Day 114	33.3% 1/3 • Number of events 1 • Baseline to Day 114
Gastrointestinal disorders Constipation	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Gastrointestinal disorders Mouth ulceration	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Injury, poisoning and procedural complications Urinary tract infection	12.5% 2/16 • Number of events 2 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Infections and infestations Ear infection	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Infections and infestations Sinusitis	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Injury, poisoning and procedural complications Ligament sprain	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Injury, poisoning and procedural complications Muscle strain	0.00% 0/16 • Baseline to Day 114	33.3% 1/3 • Number of events 1 • Baseline to Day 114
Injury, poisoning and procedural complications Skin abrasion	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations Blood cholesterol increased	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations Blood creatine phosphokinase increased	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations Blood pressure increased	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations Electrocardiogram abnormal	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations Low density lipoprotein increased	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Investigations White blood cell count increased	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Metabolism and nutrition disorders Hypokalemia	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Skin and subcutaneous tissue disorders Rash erythematous	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Vascular disorders Essential hypertension	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114
Infections and infestations COVID-19 pneumonia	6.2% 1/16 • Number of events 1 • Baseline to Day 114	0.00% 0/3 • Baseline to Day 114

Additional Information

Ajay Aggarwal

Aclaris Therapeutics, Inc.

Phone: 484-540-6296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place