## Protocol Section
### Identification Module
**NCT ID:** NCT05516979

**Acronym:** EXPAND

**Brief Title:** A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment

**Official Title:** A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment

#### Organization Study ID Info
**ID:** SynAct-CS007
#### Organization
**Class:** INDUSTRY
**Full Name:** SynAct Pharma Aps
### Status Module
#### Completion Date
**Date:** 2023-07-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-26

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2022-08-26
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-24
**Study First Submit QC Date:** 2022-08-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** NBCD A/S

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** SynAct Pharma Aps

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 127

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment period of 12 weeks given as 1 tablet daily

**Intervention Names:**

- Drug: 100 mg AP1189

**Label:** 100 mg AP1189

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Treatment period of 12 weeks given as 1 tablet daily

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 100 mg AP1189

**Description:** AP1189 tablets for oral use

**Name:** 100 mg AP1189

**Other Names:**

- AP1189 tablets for oral use

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Matching placebo for oral use

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo

**Measure:** Number of reported AEs

**Time Frame:** 12 weeks

**Description:** The change in American College of Rheumatology 20% (ACR20) compared to baseline

**Measure:** Change in ACR20

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** The change in American College of Rheumatology 50% (ACR50) compared to baseline

**Measure:** Change in ACR50

**Time Frame:** 12 weeks

**Description:** The change in American College of Rheumatology 70% (ACR70) compared to baseline

**Measure:** Change in ACR70

**Time Frame:** 12 weeks

**Description:** The change Clinical Disease Activity Index (CDAI) compared to baseline

**Measure:** Change in (CDAI)

**Time Frame:** 12 weeks

**Description:** The change in DAS-28, based on a CRP value, compare to baseline

**Measure:** Change in DAS-28

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Main Inclusion Criteria:

* Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III
* ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts).
* Candidate for MTX treatment
* Is about to begin treatment with MTX
* Must meet at least one of the following parameters at Screening:

  1. positive result for anti-CCP or RF
  2. Serum CRP ≥ 6 mg/L
* Highly active RA (CDAI \> 22) at screening and baseline
* Negative QuantiFERON-in-Tube test (QFG-IT)
* Females of child-bearing potential must use of highly effective birth control method

Main Exclusion Criteria:

* Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
* Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
* Prior history of or current inflammatory joint disease other than RA
* Subjects with fibromyalgia
* Use of hydroxychloroquine within 4 weeks prior the Screening Visit
* Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
* Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
* Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
* Have prior renal transplant, current renal dialysis, or severe renal insufficiency
* Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
* Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
* Neuropathies or other painful conditions that might interfere with pain evaluation
* Body weight of \>150 kg
* HBsAg positive and/or Anti-HBc with sign of current infection.

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chișinău

**Country:** Moldova, Republic of

**Facility:** Timofei Mosneaga Republican Clinical Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

### Misc Info Module

- Version Holder: 2024-05-24
